Suture tie device system and applicator therefor

ABSTRACT

A variety of configurations for suture tie devices and suture tie device applicators, as well as methods of suturing, are disclosed. The suture tie devices generally include at least one leg member having a curved or angled distal, tissue engaging portion. A trying member unidirectionally or bidirectionally displaceable along the leg member can optionally be provided. Engagement of a leg distal portion with a generally opposed leg distal portion or the tying member forms a suture loop which positions organ or tissue material between the curved or angled legs and the tying member. The tying member can be advanced toward the leg member so as to provide a variable extent of suture tension. Apparatus for installing the suture tie devices and suturing methods are also disclosed.

This application is a continuation-in-part of presently-pending patentapplication Ser. No. 049,504 of InBae Yoon that was filed on May 14,1987, now abandoned, the disclosure of which is incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to surgical suturing apparatusand suturing procedures and, more particularly, to suture tie devicespreferably and advantageously made of bioabsorbable materials that areparticularly useful in endoscopic surgery, applicators for such suturetie devices, and methods of suturing using such suture tie devices.

2. Discussion of the Related Art

Suturing of bodily tissue is a time consuming part of most surgicalprocedures, including both open surgery and endoscopic or closedsurgery. As used throughout this disclosure, the term "open" surgeryrelates to surgery wherein the surgeon gains access to the surgical siteby way of a relatively large incision formed in the outer surface of thepatient's body, whereas the terms "endoscopic" and "closed" surgeryrelate to surgery wherein the surgeon gains access to the surgical siteby way of one or more relatively small portals formed in the outersurface of the patient's body through which one or more surgicalinstruments can be introduced to the surgical site. A variety ofinstruments, such as endoscopes, forceps, cutters, and applicators andthe like, can be introduced through the portals to the surgical site.Commonly performed endoscopic surgical procedures include arthroscopy,laparoscopy (pelviscopy), gastroentroscopy, and laryngobronchoscopy.

Prior to the development of the subject suture device, suturing had beenaccomplished through the use of a sharp, curved metal suture needleattached to the end of a length of thread-like suture material. Thesurgeon or surgical attendant would extend the suture needle andtrailing suture material through the tissue to be joined by the suture,after which the suture material would be tied into a knot andmanipulated such that the knot could be advanced to the tissue site andadjusted for tension in order to accommodate the particular type oftissue being sutured and to control and account for approximation,occlusion, attachment, and other conditions of the tissue. The abilityto control tension is extremely important to the surgeon regardless ofthe type of surgical procedure being performed; however, knotting of thesuture material is time consuming and tedious work, particularly inmicrosurgery and endoscopic surgery. For example, suturing duringmicrosurgery procedures is necessarily tedious and time consuming due tothe reduced-size of the suture needle and suture material, and theconcomitant difficulty in manipulating the reduced-size suture needlethrough the tissue and the tying of a knot in the suture material, allof which is performed by the surgeon while viewing the surgical sitethrough various image magnifying devices. With respect to endoscopicsurgery, suturing and tying knots represent an even more time consumingprocedure due to the narrow confines of the endoscopic instruments.Accordingly, while endoscopic surgery would be preferred for manysurgical procedures, the advantages are often outweighed by thedisadvantages caused by the length of time required to complete theendoscopic surgical procedure, which time is greatly extended due to thedifficulty and amount of time required for suturing.

There have been many attempts to provide devices to take the place ofconventional suturing with a suture needle and a length of suturematerial. However, such prior art devices have essentially consisted ofstaples, clips, clamps, or other fasteners that do not provide theadjustability in tension that can be obtained by the surgeon incidentknotting and advancing a length of suture material to the tissue to besutured. U.S. Pat. Nos. 3,827,277 to Weston; 4,060,089 to Noiles;4,490,326 to Beroff et al.; 4,513,746 to Aranyi et al.; 4,532,926 toO'Holla; 4,548,202 to Duncan; 4,573,469 to Golden; 4,590,937 to Deniega;4,595,007 to Meride; 4,602,634 to Barkley; 4,646,741 to Smith; 4,671,280to Dorband et al.; 4,719,917 to Barrows et al; and 4,741,337 to Smith etal. are representative of such prior art devices for use in place ofconventional suturing. Many of these prior art devices are made ofbioabsorbable materials such that the devices are absorbed over timeinto the bodily tissue and do not have to be removed after the tissuehas healed.

There exist many compositions useful as bioabsorbable materials asrepresented by the above patents and by U.S. Pat. Nos. 3,739,773 toSchmitt et al.; 3,797,499 to Schneider; 4,141,087 to Shalaby et al.;4,300,565 and 4,523,591 to Kaplan et al.; and 4,649,921 to Koelmel etal., which discuss characteristics of various bioabsorbable materialsand medical devices desirably manufactured of such materials, suchmedical devices being of a type designed to be engaged in, embedded in,or otherwise attached to various types of bodily tissue, such as bone,muscle, internal organs, skin and other soft tissue, to remain in placein the tissue until the device is absorbed into the body.

U.S. Pat. No. 3,570,497 to Lemole discloses a suture device formed of aneedle with a piercing point extending from a latch cord carryingnotches designed to pass through a latch collar. The latch cord isresilient so as to be curved upon itself to form a suture stitch withoutrequiring tying of knot. However, the latching function does not providethe same degree of tension control as can be obtained from knotting alength of suture material. U.S. Pat. No. 4,548,202 to Duncan disclosesuse of a similar structure in a tissue fastener device, in thatserrations or angled barbs are provided along spaced legs passingthrough tissue to be engaged by an apertured receiver or a flexiblefilament mesh. U.S. Pat. No. 3,123,077 to Alcamo discloses a surgicalsuture device having raised projections, depressions or teeth such asbarbs or spicules to snag or penetrate tissue so as to hold a sewnincision or wound.

Endoscopic surgery is generally preferred over open surgery due to thegreatly reduced trauma and wound healing time for the patient, and dueto the concomitant cost savings associated with shorter hospital staysand the ability to perform some forms of surgery without generalanesthesia and in non-hospital or outpatient surgery sites. Accordingly,there has been much effort spent to develop techniques to facilitatesuturing so as to further reduce the total duration of surgicalprocedures. Alternative suturing techniques that have been proposed haveincluded electric coagulation, mechanical devices such as clips, clampsand staples, and lasers. However, no well-accepted alternative has yetbeen found, since suturing and tying are essential and vital parts ofmost surgical procedures due to the advantages discussed above withrespect to the known alternatives. That is, to date, the proposedalternatives have had disadvantages which outweigh any benefits they mayhave conferred, chief amongst the disadvantages being an increasedhealth and safety risk to the patient. Furthermore, these proposedsuturing devices and procedures do not provide the surgeon with theadvantages of suturing and tying and, as a whole, are not useful in awide range of procedures to allow expansion of the areas in whichendoscopic surgery can be effectively performed. Thus, there is a greatneed for new and advanced suture devices, particularly ones that areapplicable in endoscopic surgery, that afford surgeons all of theadvantages of knot tying and suture tensioning, and which can be appliedin a time-efficient and effective manner.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide avariety of suture tie devices that are particularly useful in endoscopicsurgery and that overcome the above-mentioned disadvantages of the priorart suture tie devices.

Another object of the present invention is to eliminate conventional,time consuming suturing and tying procedures associated with manysurgical procedures by providing a variety of suture tie devices andapplicators therefor that permit suturing and tying functions to beaccomplished simply and expediently.

A further object of the present invention is to replace conventionalsuture needles and clips with suture tie devices capable of penetratingtissue and forming a suture loop of user-selectable and variable size toprovide the surgeon with a high degree of suture tying control.

Another object of the present invention is to provide a variety ofapplicators for manipulating and applying various configurations ofsuture tie devices

The present invention relates generally to a suture tie device forsuturing bodily tissue that is formed of one or more legs of suturematerial. A locking/tying member can optionally be provided that isselectively displaceable along one or more of the device legs so as tocooperate with the distal portion of the device to form a suture loop.The one or more legs can be configured as a tissue penetrating orgrasping leg to further facilitate installation of the suture tiedevice. In alternate arrangements, the suture tie device can be formedfrom a predetermined length of flexible or semi-rigid bio-absorbable ornon-bio-absorbable material. The locking/tying member can be arranged tobe selectively displaceable along the length of suture material and canbe dimensioned to receive a free end of the suture material so as toform a suture loop. The locking member can also be configured as arigid, semi-rigid or generally elastic member and can be arranged so asto be displaceable along the device leg or length of suture material ina predetermined single direction only, or to be bi-directionallydisplaceable therealong.

An applicator for suturing bodily tissue with one or more suture tiedevices such as those described above is also provided. The applicatorincludes means for storing a plurality of suture tie devices, andactuating means for delivering a suture tie device from the storingmeans to one or more distal penetrating needles or forceps such that aplurality of sutures can be placed in the bodily tissue without removingthe applicator from the suture site. Means is provided for penetratingthe tissue to be sutured and for engaging and/or displacing thelocking/tying member of the suture tie device relative to the device legor suture material to effect suture tying.

The invention relates further to methods of suturing bodily tissue,occluding tubular vessels, and closing tissue apertures. The suturingmethod includes the steps of penetrating the bodily tissue with thedistal end of one or more applicator needles, forceps, or the leg of thesuture tie device, and selectively displacing a locking/tying memberalong the tissue penetrating leg or length of suture material toward thedistal end thereof to a position at which the locking/tying membercooperates with the distal end to form a suture loop. The suture loopcan be appropriately tensioned to provide the desired extent of tissueapproximation.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects and advantages of the present invention will becomeapparent from the following description of the preferred embodimentstaken in conjunction with the accompanying drawings, in which:

FIG. 1 is a sectional side view of a suture tie device in accordancewith the present invention;

FIGS. 2 and 3 are sectional side views of the suture tie device of FIG.1 during and after suturing, respectively;

FIGS. 4, 5, 6, 7, 8, and 10 are sectional side views of alternativeaspects of the suture tie device depicted in FIG. 1;

FIG. 9 is a cross-sectional view of the suture tie device depicted inFIG. 8 with a portion thereof removed to illustrate further details ofthe device;

FIGS. 11, 12, 13 and 14 are sectional side views of alternative aspectsof the suture tie device according to the present invention in which thelocking/tying members thereof are arranged so as to be selectivelydisplaceable in either the distal or proximal direction;

FIG. 15 is an exploded sectional side view of a further alternativeaspect of a suture tie device according to the present invention;

FIG. 16 is a sectional side view of an alternative configuration of atissue penetrating leg for use in the device depicted in FIG. 15;

FIGS. 17 and 18 are sectional side views of a further aspect of a suturetie device according to the present invention;

FIGS. 19A through 19C are sectional side views of an alternativearrangement of a suture tie device according to the present inventionillustrating various stages of engagement incident to suturing;

FIG. 20 is an exploded side view of a modification of the suture tiedevice depicted in FIGS. 19A through 19C;

FIG. 21 is a side view, partly in section, of one embodiment of anapplicator for the application of suture tie devices illustrated inFIGS. 1 through 20 of the present invention;

FIG. 22A is a side view of the distal portion of the outer tubularmember of the applicator of FIG. 21;

FIG. 22B is a frontal view of the inner cartridge tubular member of theapplicator of FIG. 21;

FIG. 22C is a side view, partially in section, of an inner cartridgetubular member of the applicator of FIG. 21 showing further details ofits structure;

FIGS. 22D and 22E are sectional side views of modifications of theextendable actuating rod of the device depicted in FIG. 21;

FIG. 23 is a side view, partially in section, of an alternativearrangement of a suture tie device applicator;

FIG. 24A is a side view of the distal portion the outer tubular memberof the applicator of FIG. 23;

FIG. 24B is a frontal view of the inner cartridge tubular member of theapplicator of FIG. 23 showing the arrangement of guide members foradvancing the locking/tying member of each suture tie device;

FIG. 24C is a sectional side view of the distal portion cf the innercartridge tubular member of the applicator of FIG. 23;

FIG. 25 is a side view, partially in section, of a further arrangementfor a suture tie device applicator according to the present inventionfor the application of suture tie devices illustrated in FIGS. 1 through20;

FIG. 26 is a sectional side view of the cartridge and intermediatetubular members of the applicator of FIG. 25;

FIG. 27 is a side view, partially in section, of a further arrangementfor a suture tie device applicator according to the present invention;

FIG. 28 is a sectional side view of the distal portion of the applicatorof FIG. 27;

FIG. 29 is a side view, partially in section, of a further embodiment ofa suture tie device applicator according to the present invention;

FIG. 30 is a sectional side view of a further arrangement for a suturetie device according to the present invention;

FIGS. 31 and 35 are sectional side views of various arrangements for thedistal portions of the inner cartridge and intermediate tubular membersof various embodiments of the suture tie device applicators of FIGS. 21,23, 25, 27, 29 and 37;

FIGS. 32-34 are frontal views of various arrangements for the distal endof the curved portions of either the intermediate and/or cartridgetubular member of the applicators of FIGS. 25, 27, 29 and 30,respectively;

FIGS. 36A and 37 through 42 are sectional side views illustratingvarious configurations of a multiple-leg suture tie device in accordancewith the subject invention;

FIG. 36B depicts a sectional side view of the locking/tying member ofFIG. 36A;

FIGS. 43A-43F are side views, partially in section, of variousconfigurations for the distal ends of the suture tie devices depicted inFIGS. 36A-39;

FIGS. 44A and 44B are side views, partially in section, of variousconfigurations for the distal ends of the suture tie devices depicted inFIGS. 40 and 41;

FIGS. 45A-45D are broken side views, partially in section, of variousconfigurations for the distal ends of the suture tie device depicted inFIGS. 40 and 41;

FIGS. 46 and 47 are broken isometric views depicting sections of the legportions of the suture tie devices of the subject invention;

FIGS. 48A and 48B illustrate use of the device depicted in FIG. 36A inclosing off tubular member;

FIGS. 49A-49C illustrate in sequence use of the device depicted in FIG.37 during suturing;

FIG. 51 illustrates sequential operation of a further alternative suturetie device in accordance with the subject invention;

FIG. 52 is a sectional side view of an applicator for applying themultiple leg suture tie devices of the subject invention;

FIG. 53 is an enlarged view of a portion of the applicator of FIG. 52;

FIGS. 54 and 59 are side view of the distal end of the applicatordepicted in FIG. 52 at different stages of operation;

FIG. 55 is an end view of the applicator segment depicted in FIG. 54;

FIGS. 56 and 57 are side views of alternative arrangements for thedistal end of the device of FIGS. 52 and 53;

FIG. 58 is a sectional side view showing further details of the distalend of the applicator depicted in FIGS. 52 an 53;

FIG. 60 is a side view of an alternative distal end adjusting mechanismfor use with the applicator depicted in FIGS. 52 and 53;

FIG. 61 is a sectional side view of an alternative suture tie deviceapplicator for applying multiple leg suture tie devices as shown inFIGS. 36A through 41;

FIG. 62 is an end view of the distal end of the applicator of FIG. 61;

FIG. 63 is a side view of the distal end of the applicator of FIG. 61;

FIGS. 64A-64C and 66 are side views of the distal tips of the applicatorforceps of FIG. 61;

FIGS. 65 and 67 are side views of alternative forcep configurations;

FIGS. 68A and 68B are side and end views, respectively, of the distalend of one of the applicator tubular members; and

FIG. 69 is a sectional side view of the distal end of the applicator andforceps thereof of FIG. 61 with a suture tie device mounted therein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the drawings, wherein like reference characterscorrespond to like components throughout the various views, and withparticular reference to FIGS. 1 through 3, there is depicted a suturetie device 30 in accordance with the present invention that includes aleg 32 having a preferably rigid proximal portion 34 of relatively largediameter and a distal tissue penetrating portion 36 of diminisheddiameter. As used throughout this disclosure, the term "proximal" andvariants thereof refers to the right hand side of a drawing, whereas theterm "distal" and its variants refer to the left hand side of thedrawing. The distal portion 36 is provided with a suture needle orhook-like or curved configuration that terminates at a sharp distal end38 and defines a tissue receiving space 39 having an open side adjacentdistal end 38 that is positioned between the distal end 38 and the leg32. The curved configuration of the distal tissue penetrating portion 36is similar to the configuration of a conventional suture needle and,preferably, is slender and configured so as to taper inwardly to a sharppoint at its distal end 38. A locking/tying member 40 at leastpartially, and preferably substantially, circumscribes the proximalportion 34 of the device 30 in a ring-like fashion. Any one or both ofthe leg 32 and locking/tying member 40 can be completely or partiallyformed of a bioabsorbable or non-bioabsorbable material, or acombination thereof, which can be provided with appropriate physicalcharacteristics so as to be entirely or partially rigid, semi-rigid orflexible, elastic, resilient or malleable in accordance with the suturetie device's 30 intended utilization. The locking/tying member 40 ispreferably formed as a rigid or semi-rigid member and defines a passage41 extending therethrough having an internal configuration or luminalsurface that is configured to cooperate with a plurality of angled teeth42 protruding from the outer surface of the leg 32 such that thelocking/tying member 40 is selectively displaceable only distally, inthe direction of arrow A (FIG. 1), from the proximal end toward thedistal end of leg 32.

As illustrated in FIG. 2, the interior surface of the locking/tyingmember 40 is preferably provided with a plurality of angled teeth 44arranged at complementary angles to the angle of the teeth 42 of the leg32 for engaging the leg teeth 42 to prevent proximal, i.e., rearward,movement of the locking/tying member 40. The angled teeth 42 can bedisposed along the leg 32 in a variety of configurations, such as toextend from the entire or a predetermined portion of the peripheralsurface of the leg, or so as to extend from a longitudinal recess orgroove formed along the length of the leg 32. Furthermore, variousconfigurations can be utilized to permit only the distal movement cf thelocking/tying member 40. Such movement-restricting configurationsinclude whisker-like filaments, barbs, ridges, angled pins or otherprotrusions which extend from the leg, some or all of which can beangled in the distal direction to prevent the proximal movement of alocking/tying member 40.

In use, the suture tie device 30 is held in a cradle of an applicator,examples of which are seen in FIGS. 21, 23, 25, 27 and 29 and describedin detail below, and manipulated in a manner similar to the movement ofa conventional suture needle so as to extend the sharp distal end 38 ofthe device to penetrate tissue to be sutured, with or without theassistance in tissue penetration of the various suture tie deviceapplicators described below. Once the tissue penetrating portion 36 hasbeen manipulated so as to extend through the tissue, the locking/tyingmember 40 is displaced distally toward the distal end 38, as illustratedin FIG. 2, to cooperate with the distal tissue penetrating portion 36 toclose or substantially close the open side of the tissue receiving space39 and form a suture loop with the tissue engaged thereby. The extent ofdistal movement of the locking/tying member 40 determines the size ofthe suture loop, the compression on the tissue sutured thereby, andultimately completion of the tying of the suture loop. The degree oftension of the tie can also be adjustable by the movement of thelocking/tying member distally from a position of initial approximationof the tissue structures to a position of full tying of the suture loopwith maximum tension of the tie. Once the locking/tying member 40 hasbeen moved the desired extent to securely tie the suture loop to adesired degree of tension, the protruding proximal portion of the legextending beyond the locking/tying member 40 can be severed, as shown bysevering line "S" in FIG. 2, at an appropriate position to allow thetied suture loop to remain intact. The severed portion of the leg canthereafter be removed from the surgical site for disposal.

A modified suture tie device 48 according to the present invention isillustrated in FIG. 4. The modified device 48 differs from suture tiedevice 30 depicted in FIGS. 1-3 primarily in the configuration of theleg and locking/tying member. To this end, the distal portion 50 of leg52 has more of a curved suture needle-like or hook-like configurationfor grasping a larger amount of tissue, whereas the proximal portion 54thereof is of comparatively smaller diameter. The locking/tying member56 is provided with a central passage 58 therethrough having a pluralityof angled teeth protruding therefrom to engage correspondingly-angledteeth 60 protruding from the leg. As mentioned above, these teeth-likecoupling configurations can be replaced with other types of protrusionsor indentations which also inhibit or prevent undesired proximalmovement of the locking/tying member. A small recess 62 can be providedat the upper, distal end of locking/tying member 56 to receive the sharpdistal end 64 of the tissue penetrating distal portion 50, while alarger recess 66 having a plurality of angled teeth or other suitableleg protrusion-engaging members 44 therealong to cooperate with andreceive the angled teeth or other protruding members 0 along the curveddistal portion can be provided at the lower of the locking/tying member.Accordingly, the sharp distal point 64 of the suture tie device can beprotected from exposure to surrounding structures, surgical instrumentsand the like by being received in recess 62, while recess 66accommodates the curvature of the distal portion of the suture tiedevice to allow the movement of the locking/tying member 56 therealongas desired to produce the desired degree of locking tension for tissueapproximation and/or suture tying.

The suture tie device 68 illustrated in FIG. 5 is substantially similarto the embodiments described above and depicted in FIGS. 1-4, with theexception that the proximal portion 70 of the tissue penetrating leg 72is configured so as to extend through a passage 74 formed in the bottomof locking/tying member 76. The locking/tying member is provided with aprotruding portion 78 which extends outwardly from its distal face. Thedistal end of the protruding portion 78 includes a recessed space 77that is dimensioned to accommodate the curved distal portion 71 of thepenetrating leg 72 and any tissue sutured thereby. A recess 80 is formedin the member 76 to receive the sharp distal end 82 of the tissuepenetrating distal portion 71 upon engagement of the distal portion withthe locking/tying member. The tissue receiving space 79 is configured soas to be generally more open, i.e., less restricted by leg 70, thancorresponding space 39 of the arrangement described in FIGS. 1-4;however, the lateral, open sides of tissue receiving space 79 arelikewise arranged so as to be selectively closable by the locking/tyingmember 76 to tie the suture loop.

The suture tie device 84 illustrated in FIG. 6 depicts a furthermodification of the suture tie device of the subject application asdepicted in FIG. 5, with the exception that the tissue penetrating leg86 has a distal portion which can be provided with either a triangular85 or rectangular 85' (depicted in phantom) cross-sectionalconfiguration. The triangular configuration 85 is preferred, for itprovides for the secure grasping and suturing of a relatively greateramount of tissue. The distal face of the locking/tying member 84 can beprovided with a variety of different configurations, such as with agenerally planar face, as shown at 83', and optionally as with arecessed space 77 to accommodate the tissue sutured by distal portion85'. Alternatively, the distal face can be configured to provide agenerally triangular or pyramidal protrusion 83 (depicted in phantom)that can optionally be provided with a recessed space 77 at the distaltip of protrusion 83 to accommodate the tissue sutured byangularly-configured distal portion 85.

The suture tie device 88, illustrated in FIG. 7, is similar to thesuture tie device 48 depicted in FIG. 4 and described above, with theexception that the proximal portion 90 of the leg 32 passes through apassage 41 formed at the top of locking/tying member 92 to create arelatively large, generally "C" or "V"-shaped space 91 in the curvedsuture needle-like, tissue-penetrating distal portion 94. By providing aslight proximally-extending, needle-like protrusion 93 extending fromtissue-penetrating portion 94, a plurality of segments of tissue can beengaged within spaces 91 and 95 thereof and simultaneously tied by thedistal movement of locking/tying member 92 along leg 32 in the mannerdescribed above.

The arrangement of the suture tie device 96 shown in FIGS. 8 and 9provides a relatively elongated, narrow, hook-like tissue penetratingdistal portion 98 with a relatively thick proximal leg portion 100. Alongitudinal groove 101 is disposed along the upper and lower length ofthe leg thereof within which are provided a plurality of slight ridges102 and recesses 103 that are adapted to cooperate with the plurality ofangled filaments 104 extending from the internal surface of the centralpassage of the locking/tying member 106 so as to provide selectivelyactuable groove coupling means. The filaments are angled such that thelocking/tying member can be selectively displaced in a distal directiononly. The locking/tying member and groove coupling means described aboveand illustrated in FIGS. 8 and 9 can be reversed such that the filaments104 extend from leg 100 of the suture tie device and cooperate withridges 102 or recesses 103 along the internal surface of thelocking/tying member's central passage. Suture tie device 96 isparticularly useful for plugging or occluding holes in tissue or organstructures and for suturing damaged regions which are located in deepand/or narrow spaces, since the shape of the spaces defined by thedistal tissue penetrating portion 98 is relatively narrow and ovate.

As seen in FIG. 10, suture tie device 96' can also be provided with aplurality of whisker-like filaments 105 on the surface of the leg 100that are angled to cooperate with indentations, grooves, or micro-holes104' formed along the interior of the passage of the locking/tyingmember 106' to ensure unidirectional, distal movement of thelocking/tying member while preventing its proximal (backward) movement.

FIG. 11 shows a suture tie device modification 97 of the suture tiedevice 96 depicted in FIGS. 8 and 9 that provides for bi-directionalmovement of the locking member along the leg of the device. In thedepicted arrangement of FIG. 10, the leg 100 of the device is configuredas a generally hollow tubular member and is provided along its innersurface with a plurality of tooth-like protrusions 109. Mounted withinthe central passage 41 of the locking/tying member 107 is a pair ofopposed, inwardly-protruding arms 111 which pass through longitudinalslots 113 formed along the upper and lower sides of the tissuepenetrating leg 100. Attached to the ends of each arm 111 is a plate 115having a plurality of tooth-like protrusions 117 on the sides which facethe protruding teeth 109 of the leg. In this leg engaging arrangement,the locking/tying member 107 is configured as an elastically-deformablemember, and a predetermined amount of space is provided between thepassage wall of the locking/tying member and the outer surface of thepenetrating leg 100 such that, when the locking/tying member 107 iscompressed along its upper and lower surfaces, the plate's teeth 117disengage from the leg's inner teeth 109 to disengage the locking/tyingmember from the leg to permit selective or proximal movement along theleg. However, once the locking/tying member 107 is released, the plate'steeth 117 engage with the leg's internal teeth 109 such that thelocking/tying member is locked at that position.

FIG. 12 shows a modification 177 of the components for thebi-directionally operable locking/tying member and leg-engaging meansdescribed in FIG. 11, in which the hollow leg 100 of the suture tiedevice is provided with a plurality of microholes 123 along its interiorsurface. The locking/tying member 125 is provided with a pair of opposedarms 119 which protrude inwardly and pass through longitudinal slots 127along the upper and lower sides of the leg of the suture tie device.Positioned at the free end of each arm is one or more hook-like members121 which cooperate with the microholes 123 of the leg to lock thelocking/tying member 125 in place on the leg. When the locking/tyingmember is compressed as described above, the member 125 can beselectively displaced distally or proximally along the leg 100 to adesired position, where it can then be locked into position upon releaseof the locking/tying member, thereby urging the hook-like members 121 toextend into the microholes 123 in the manner described above with theplate teeth 117 and leg internal teeth 109.

FIG. 13 shows suture tie device 129 in which the bi-directionallyoperable locking/tying member 131 is provided with a pair of recesses133 and 135 to accommodate distal penetrating portion 137 and sharpdistal tip 139, respectively, when the locking/tying member 131 is moveddistally. Positioned on the surface of the leg are a plurality ofumbilicated grooves or ridges 145 which can cooperate with the ends ofinwardly-extending pivoting bars 143 of the locking/tying member 131.These pivoting bars 143 extend outwardly from recess 41 to a pivotingpoint 141, which joins each pivoting bar 143 to a corresponding rigidbar 119' which extends from the interior surface of the device 131 intoits internal passage 41. The pivoting bar 143 is angled to an end whichcan cooperate with the grooves 145. When the locking/tying member 13 iscompressed from the top and bottom, bars 119' move inwardly, causing theangled bars 143 to collapse away from the leg by the pivot point topermit movement of the locking/tying member in either direction,distally or proximally, until it reaches a desired position, at whichpoint the locking/tying member can be released and the pivoting bars 143returned to their initial position with their ends locked within thegrooves of the leg to lock the locking/tying member in place along theleg.

FIG. 14 illustrates a modification 147 of suture tie devices 97 and 177,in which the bi-directionally operable locking/tying member 149 isprovided with a pair of opposed bilateral bars or rods 151 whichprotrude inwardly from plates 151'. Each bar or rod 151 is provided witha longitudinally oriented plate or bar 153 having a plurality ofhook-like members 155 which can cooperate with the microholes 123 formedin the leg of the device 147. The hollow leg of suture tie device 147 isprovided with a pair of bilateral slots 127 extending longitudinally toallow bilateral bars 151 of the locking/tying member to move distallyand proximally upon compression and advancement of the locking/tyingmember. Microholes 123 accommodate the hook-like members 155 when thelocking/tying member is released to lock the device 149 at a desiredposition along the surface of the leg 100. All of the locking/tyingmembers illustrated in FIGS. 11-14 are preferably made of a rigid orsemi-rigid resilient or elastic bioabsorbable or non-bioabsorbablematerial to facilitate control of its distal and proximal movement.

A further suture tie device arrangement is depicted at 108 in FIG. 15and includes a tissue penetrating leg 110 having a polygonally-shapeddistal tissue penetrating portion 112 which terminates at sharp distalend 114 and a proximal shoulder 25, as shown in FIG. 15, or a tissuepenetrating leg 110' having a generally rectangular distal tissuepenetrating end 112' terminating at a sharp distal point 114 andproximal shoulder 25, as shown in FIG. 16. A locking/tying member 116 isprovided with a passage 118 that extends through the bottom thereof foreither leg 110 or 110', and a recess 120 at the top for receiving distalend 114 when the locking/tying member 116 is moved distally to tie thesuture loop. When the locking/tying member 116 is utilized alone witheither leg 110 or 110', the locking/tying member itself can be moveddistally to tie the suture loop.

An alternative to using locking/tying member 116 alone is to use acombination of locking/tying member 116 in connection with a plug 122with either leg 110 or 110'. The polygonally shaped distal end 126 ofthe plug 122 corresponds to the polygonally-shaped distal portion 112 ofleg 110, whereas the blunt distal end 126' (depicted in phantom)corresponds to the rectangular distal portion 112' for use therewith.When the plug 122 is used with the leg 110, the proximal portion of leg110' passes through the lower passage 118 of locking/tying member 116,which is provided with a relatively wide central passage 119 forreceiving plug 122. A plurality of barbs 124, ridges, filaments, ormicroholes can be formed on the surface of plug 122 to correspond toprotrusions along the internal surface of passage 119 to permit forselective displacement of the plug 122 only in the distal directionuntil its proximal shoulder 123 meets the proximal face of locking/tyingmember 116, thereby tying the adjustable suture loop. Alternatively,because the use of both the plug 122 and the locking/tying member 116provides both a proximal movement of leg 110 or 110' and a simultaneousdistal movement of plug 122 in relation to locking/tying member 116, thecavities 118 and 119, as well as the leg and plug members 110, 122 canbe appropriately dimensioned such that simultaneous movement of the leg110 and plug 122 toward each other allows the tightening of the plug andthe leg, even in the absence of any coupling means on the surfaces ofeither the plug or the leg.

A further arrangement for a suture tie device 128, illustrated in FIG.17, includes a tubular or hollow tissue penetrating leg 130 whichdefines a cavity 131 and includes a distal tissue penetrating portion132 terminating at an open sharp distal end 134 and an outwardly flaredor tapered proximal shoulder 135. The locking/tying member 136 isprovided with upper and lower passages 138 and 140, respectively, forreceiving rigid or semi-flexible upper and lower arms 142 and 144 whichextend in a distal direction from a push plate 146. The proximalshoulder 135 of the leg 130 extends through the lower passage 140 oflocking/tying member 136 to prevent the leg 130 from passing distallyoutwardly therethrough. The arms 142 and 144 have a diameter selected topermit them to be received within the respective passages 138 and 140such that the distal end 134 of the leg 130 can be received into thedistal end of arm 142' instead of receiving the distal end of arm 142internally. In operation, after tissue penetration, the push plate 146is moved distally such that the distal portion of arm 142 or 142' entersor receives the distal end 134 of the leg 130, and the lower arm 144passes through the lumen of leg 130 until plate 146 meets the proximalshoulder of leg 130, thereby completing a suture loop which can,thereafter, be adjusted in size by the movement of locking/tying member136 distally until the loop is ultimately tied and tensioned. Asdescribed above, one-way movement of the locking/tying member 136 can beeffected by suitable coupling means as described above.

A suture tie device 148 as illustrated in FIG. 18 depicts anotherarrangement for creating a suture loop by providing for a length ofsuture material to circulate through the leg of the suture tie deviceinstead of having the locking/tying member contact with the distal endof the leg to create the suture loop. The suture tie device 148 includesa hollow tissue penetrating leg 150 having a proximal shoulder 135, anda locking/tying member 152, all of which are similar to the likecomponents described above in connection with FIG. 17. The suture tiedevice 148 further includes a length of suture material 154 which can berigid, semi-rigid, flexible, malleable or resilient, bioabsorbable, ornon-bioabsorbable, that is provided with a small, outwardly-extending ortapered proximal shoulder 155 which is dimensioned so as to inhibitpassage through the upper passage of locking/tying member 152. Thislength of suture material passes distally through the upper passage 138of the locking/tying member 152 to be received internally in the opendistal end 156 of the tissue penetrating distal portion of leg 150 tocomplete a suture loop. Once the suture material has been received inthe leg 150, the locking/tying member 152 can be moved in a one-wayfashion distally to diminish the size of the suture loop until it iscompletely tied. Alternatively, a length of suture material 154' can beprovided that is entirely or partially hollow, and leg 150 can beconfigured so as to be either hollow or solid, such that the hollowsuture material 154', when pushed distally through the upper passage oflocking/tying member 152, receives the sharp open or closed distal end156 internally rather than passing into the leg to create a suture loop.Thereafter, locking/tying member 152 can be moved distally to diminishthe size of the suture loop until it is completely tied. As a furtheralternative, a length of solid suture material 154 can be passeddistally through the proximal end of hollow leg 150 located within thelower passage 140 of locking/tying member 152 until the suture material154 passes distally through the entire leg 150 and exits proximally outof the open distal end 156. The suture material 154 can then passedproximally through the upper passage of locking/tying member 152 tocomplete the suture loop. Thereafter, locking/tying member 152 can bemoved in a one-way (unidirectional) fashion distally to diminish thesize of the suture loop until the loop is appropriately tied andtensioned.

A further configuration of a suture tie device 158 is illustrated inFIGS. 19A, 19B and 19C and includes a solid tissue penetrating leg 160having a proximal ring 162 extending therefrom and a distal tissuepenetrating portion 164 terminating at a sharp distal end 38'. Alocking/tying member 166 is provided in the form of a plug which mayhave coupling members 168 such as angled teeth, ridges, or filamentsextending therefrom for cooperating with a correspondingly-configuredinternal surface of a leg collar 162. A nib 170 can be provided whichextends from the upper end of the plug-like locking/tying member 166 tooverlie the sharp distal end 38' of the tissue penetrating portion 164.In use, the plug operates in a fashion similar to tee ring-likelocking/tying members described above by passing through the collar 162,as illustrated in FIGS. 19B and 19C, in a distal direction to a desiredextent to capture tissue sutured by the tissue penetrating distalportion 164. A gently curved recess 165 can optionally be formed alongthe curved convex distal end of locking/tying member 166 to accommodatethe sutured tissue or the curved distal portion 164 of leg 160 alonewhen plug 166 is moved distally through collar 162, as shown in FIGS.19B and 19C. In FIG. 19C, the sharp distal end 38' is depicted as beingcompletely covered by nib 170, and the curved distal portion 164 of leg160 is received by the recess 165, as would occur upon complete distaladvancement of the locking/tying member 166 relative to the collar 162.

FIG. 20 shows a modification 158' of the suture tie device 158 shown inFIG. 19A, in which the cradle-like penetrating leg 160' is provided witha generally U-shaped or C-shaped cross-section to create a channel orspace 161 for accommodating the suture tissue and/or to allow thepassage of a length of suture material therethrough. The channel 161which is continuous with the central passage of the collar 162' locatedat the proximal end of leg 160'. The plug-like locking/tying member 166'can be provided with a coupling configuration similar to that describedin FIG. 19A. In addition, plug 166' can also be provided with a lumen orchannel 167 which extends along the lower side, the distal curved end,and the upper side to provide for the passage of a length of suturematerial or medication therethrough.

As will be appreciated from the above discussion of various embodimentsof suture tie devices according to the present invention, the curvedsuture needle-like or hook-like tissue penetrating distal portions canbe provided with a wide variety of configurations to define spacestherein of various shapes and configurations, such as circular, oval,rectangular, rhomboid and the like, for suturing various tissue andorgan structures. The locking/tying members can be arranged so as to bemovable only distally along the tissue penetrating legs in a singledirection only by means of various cooperating structures such ascontinuous or segmented barbs, angled teeth, whisker-like filaments,microholes for engagement by corresponding microfilaments and the like,or this one-way movement may be achieved by the use of umbilicated,thread-like ridges embedded in a groove extending along the length ofthe leg so as to engage and lock whisker-like filaments or angled pinsor the like protruding from the internal surface cf the locking/tyingmember. The locking/tying members can also be arranged so as to bebi-directionally displaceable along the legs either direction by havingeither through the provision of hollow penetrating legs with teeth ormicroholes or the like and longitudinal slots which allow for distal andproximal movement of the protruding arms of the locking/tying members.The locking/tying members can be provided with plates with teeth orhooks which correspond to the internal surface configurations of thelegs, or with solid penetrating legs having grooves on the surface whichcooperate with pivoting bars or rods extending from the internal passageof the locking/tying members. Compression of these various locking/tyingmembers allows their distal or proximal movement, while their releaselocks the locking/tying member in the desired position. Thelocking/tying members themselves can also be provided with a widevariety of shapes and cross-sectional configurations. Similarly, inaccordance with the configuration of the distal tissue penetratingportions, complementary recesses can be formed in the locking/tyingmember to accommodate and cover the distal portion including the sharpdistal end, and further to accommodate tissue penetrated by the distalend such that the tissue is held within the suture loop formed by thelocking/tying member and the tissue penetrating leg. The suturingprocedure is essentially the same with all of the embodiments in that asuturing maneuver is made with the distal end of the suture tie devicealone or in conjunction with the distal end of an applicator asdescribed below to penetrate the tissue, and a looping and tyingoperation is provided by moving the locking/tying member distally adesired extent until the suture loop is completely tied around thesutured tissue. In accordance with the tissue or organ structure to besutured, the configuration of the locking/tying member (for example, aring-like or plug-like member) can be provided with a distal face havinga configuration to accommodate the tissue as well as the sharp edges ofthe distal portion of the tissue penetrating leg. The sharp distal endcan be disposed within the locking/tying member in accordance with thetissue or organ structure to be sutured and its position in the body.While the suture tie devices described above are preferably andadvantageously made of bioabsorbable material, the suture tie devicescan be made in whole or in part of partially bioabsorbable ornon-bioabsorbable material, if desired. In addition, the locking/tyingmembers can be configured so as to be rigid or resilient depending onthe arrangement of the locking, tying, and/or coupling means.

With reference to FIG. 21, there is depicted an applicator 172 comprisedgenerally of two tubular members: a cartridge member 174 and an outertubular member 206 having a tubular lumen for receiving the cartridgemember. The applicator 172 allows for the application of the varioussuture tie devices described above and depicted in FIGS. 1-20 inaccordance with the present invention. FIG. 22A shows the distal portionof only the outer tubular member 206 with its hook-like cradle 208 forreceiving one of the suture tie devices 48 for application to tissue inthe manner described in detail below. The cartridge 174, which is shownin further detail in FIGS. 22B and 22C, is a spring-loaded member whichhouses a plurality of suture tie devices, such as the suture tie device48 shown in FIG. 4, in an end-to-end serial arrangement.

With reference to FIG. 21, the cartridge 174 includes an outer tubularmember 176 having a cap 178 at is proximal end with an extendable rod180 passing through an opening in cap 178 and terminating at itsproximal end at an actuator button 182 and at its distal end at a pushermember 184 having a recess therein adapted to receive the proximal endof the last (i.e., most proximally positioned) of the plurality ofsuture tie devices 48. Various means can be provided for the extendingmechanism of the rod 180, some of which are shown in FIGS. 22C, 22D and22E. The rod 180 can be configured as two or moreconcentrically-arranged tubular members 180a, 180b which havecooperating configurations for extending the length of the rod andlocking it at a selected length such that a single suture tie device canbe released in a one-by-one fashion. For example, one of the outer orinner concentrically-arranged rods 180a, 180b can be provided with aplurality of one-way angled filaments or pins 181, and the other of thetubular members can be provided with corresponding umbilicated threadedgrooves or ridges 183, as shown in FIGS. 22C and 22D. Alternatively, therods 180a and 180b can be provided with correspondingly-threadedsurfaces 185, as shown in FIG. 22E, to ensure displacement in thedesired direction.

A helical spring 186, depicted in FIG. 21, is mounted in a displaceablehousing 187 in compression between actuator button 182 and cap 178.Positioned within cartridge tubular member 176 is a biasing means 188such as helical spring member, which is mounted in compression betweenthe proximal end of the tubular member 176 and pusher member 184. Thedistal end of the cartridge 176 is slotted to define two or moreexpandable arms 190 and 192, as seen frontally in FIG. 22B. The armsterminate at ends 194 and 196, respectively, and are each provided witha generally curved configuration which can be varied in shape toaccommodate the curved shape of the distal penetrating portion of thevarious suture tie devices shown in FIGS. 1-20.

A generally U-shaped or C-shaped handle 198 is provided for controllingoperation of the applicator device 172. The handle 198 includes proximaland distal arms 199 and 200 joined to one another by curved springportion 201. The proximal handle arm 199 terminates at a collar 214secured to the tubular member 176 that is telescopically received withinouter member 206. The distal handle arm 200 terminates at a collar 204that is secured to the proximal end of the outer tubular member 206 ofthe applicator 172 that, in turn, is attached at the bottom of itsdistal end to the fixed, hook-like cradle 208. The cradle 208 isprovided with a curved distal portion which terminates at distal end 210that can be configured in a variety of shapes so as to correspond to theconfiguration of the distal portion of the leg of the particulararrangement of suture tie device to be used with the applicator. Thedistal end 210 of the outer tubular member can be configured so as tocorrespond to the length of the distal end 64 of the suture tie device48, or it can be provided with a length that is slightly longer than thesuture tie device 48 and a configuration which permits it to function asa tissue penetrating member. Preferably, the distal end 210 is providedwith a sharp distal edge to facilitate suturing. Alternatively, thedistal end 210 can be provided with a length that is slightly shorterthan that of the suture tie device 48, so that the distal end 64 of thedevice 48 functions as the tissue penetrating member.

In use, a cartridge 174 is pre-mounted within applicator 172 or insertedthrough the open proximal end of the applicator upon removal of the cap178, and the applicator is inserted through an incision or portal formedin the exterior surface of the body of a patient and advanced to asuturing site. By depressing actuating button 182, extendable rod 180with pusher member 184 is advanced distally to urge a suture tie devicedistally so as to expand the cartridge arms 190 and 192 from one anotherand exit the cartridge to be received in the cradle 208. Once theactuating member 182 is released, the arms 190 and 192 return to theirgenerally closed (rest) position such that a space remains between armdistal ends 194 and 196 that is wide enough to allow the proximalportion of the leg of the suture tie device to pass therethrough,thereby allowing the distal ends 194 and 196 to be in position to pushthe locking/tying member distally. Once the suture tie device is sopositioned, the tissue to be sutured can be penetrated by one or both ofthe (sharpened) distal ends of the suture tie device and the sharpdistal point 210 of cradle 208. Once tissue penetration has beencompleted, handle arms 199 and 200 are squeezed toward one another apredetermined distance to distally advance the cartridge arm distal ends194 and 196 against the locking/tying member, thereby advancing thelocking/tying member distally. The locking/tying member of the device,such as member 56 of the device 48, can be advanced toward the distalend 64 a desired amount to complete a suture loop and capture thesutured tissue therebetween. Once the locking/tying member is suitablypositioned such that the suture loop is tied completely or the tissue isapproximated to a desired extent, the handle can be released and theapplicator appropriately manipulated so as to deposit the suture tiedevice in place. Excess material of the suture tie device extendingproximally of the locking/tying member can be severed with aconventional forceps instrument.

An alternative arrangement of a concentrically-arranged multi-tubularapplicator 218 for applying suture tie devices according to the presentinvention is illustrated in FIG. 23. Parts of the applicator 218 thatare identical or corresponding to parts of applicator 172 are designatedby identical reference numbers and are not described again for the sakeof brevity. The extendable rod 180 can be configured as two or moreconcentrically-arranged tubular members, as described above inconnection with FIGS. 22C-22E, and can be moved distally and proximallyin relation to one another such that the length of the entire rodextends automatically after each suture tie device is sequentiallyreleased from the cartridge. Applicator 218 is substantially similarstructurally and functionally to applicator 172 (FIG. 21), with theexception that the tubular member 176 of the cartridge terminates at ablunt, open distal end 220, whereas the outer tubular member 206terminates at its distal end at a plurality of slotted, multiple curvedarms 222. The arms 222 can be configured so as to accommodate the curveddistal portion of the various types of suture tie devices describedabove and depicted in FIGS. 1-20.

Mounted within the tubular member 176 are a plurality of spring-likeguides 224 for retaining the suture tie devices within the cartridgeagainst the force of spring 188. The guides 224, which are preferablyarranged as opposed, distally-angled pairs extending toward the interiorof the cartridge member, are provided with generally concave endsurfaces (FIG. 24B) to align the suture tie devices so that the arms cancollapse against the internal wall of the cartridge tubular member 176,as indicated by the arrows in FIG. 24C, to allow the suture tie devicesto be released from the cartridge in a sequential manner. Thedistal-most guides 224a (FIG. 24C) extend distally beyond the bluntdistal end of cartridge member 176 and serve to push the locking/tyingmember of the released suture tie device in the distal direction tocomplete the tying process.

Use of the applicator 218 is similar to that described above withrespect to applicator 172, in which a suture tie device can be releasedinto the cradle 208 by compressing button 182 toward cap 178. In analternative aspect of operation, the (inner) tubular member 176 can berotated in relation to (outer) tubular member 206, or vice versa, torelease a suture tie device into the cradle 208. Another applicatorarrangement provides that displacement of handle arms 199 and 200 towardone another upon squeezing of the handle 198 directs the blunt distalend 220 and the distal-most guide 224a of the cartridge to expand thearms 222 of the outer tubular member. Further squeezing of the handlecauses the curved distal ends of guides 224a to push the locking/tyingmember of the suture tie device distally to complete the tying function.Thereafter, an independent forcep assembly, such as a biopsy instrument,can be passed through outer tubular member 206 to sever the portion ofthe suture tie device protruding proximally of the locking/tying member.

A further arrangement for an applicator 226 is illustrated in FIGS. 25and 26 and is comprised of three concentrically-arranged tubularmembers, one of the tubular members being a cartridge member 228 forhousing a plurality of suture tie devices of the type described aboveand depicted in FIGS. 1-20 that are serially arranged and spring biaseddistally by a compression spring 188 in a manner similar to thatdescribed above in connection with the cartridge members for theapplicators 172 and 218 depicted in FIGS. 21 and 23. With reference toFIG. 26, the distal portion of the cartridge tubular member 230 isprovided with a flat, blunt distal end, whereas the distal portion ofintermediate tubular member 236 is depicted as having curved expandablearms 240. Alternatively, the respective distal end configurations can bereversed to provide the inner cartridge tubular with inwardly curvedends and the intermediate tubular member with a flat, blunt end. Thecartridge 228, as shown in FIG. 25, includes a tubular member 230 havinga cap 232 at its proximal end and an open distal end 234. Anintermediate tubular member 236 circumscribes the cartridge tubularmember 230 and is positioned between tubular member 230 and an outertubular member 242. A proximal end of the intermediate tubular issecured to a collar 238. The intermediate tubular member 236 includes atleast one pair of expandable curved arms 240 at its distal end which canbe configured in accordance with the type of suture tie device used. Theouter tubular member 242 is provided with a proximal end that is securedto a collar 244, and a distal end that is configured as a fixed,hook-like cradle 246. The cradle has a generally U-shaped or C-shapedcross-sectional configuration and terminates at a sharp point 248. AU-shaped handle 250 comprising distal and proximal arms 252 and 254joined to one another by a curved spring portion 255 is arranged suchthat a distal arm 252 is secured to collar 244 and a proximal arm 254 issecured to collar 238. Ring handles 256a and 256b can optionally beprovided along arms 252 and 254, respectively, to facilitate handlegrasping and operation. A second curved spring member 258 connectscollar 238 with a collar 259 that is secured to tubular member 230 ofthe cartridge 228 such that the inner tubular member 230 andintermediate tubular member 236 can move together to move the curveddistal end 240 of the cartridge not only to distally advance thelocking/tying member of the suture tie device, but optionally to move ormanipulate the proximal portion of the suture tie device leg for asevering action or to hold or manipulate the locking/tying member at adesired position. A finger grip 260 extending downwardly from the collar259 and spring member 258 can optionally be provided to facilitatespring member manipulation.

In use, a cartridge 228 housing a plurality of suture tie devices isloaded in the applicator 226. In order to position the distal-mostsuture tie device within the cradle 246, spring member grip 260 and arm254 of handle 250 are urged toward one another, thereby moving tubularmember 230 distally relative to intermediate tubular member 236, causingdistal end 234 to open or expand arms 240 and allowing the spring biaswithin the cartridge to push the distal-most suture tie device beyondthe expanded arms 240 and into cradle 246. When the grip 260 is thecurved arms 240 return to their rest, generally closed position due tothe bias from spring member 258 to restrict further distal movement ofthe remaining suture tie devices in the applicator. Once a suture tiedevice has been positioned within the cradle, the desired tissue ororgan structure can be sutured by penetrating the tissue with at leastone of the sharp distal ends of the hook-like cradle and the suture tiedevice in a conventional suture needle-like fashion. After penetrationof the tissue, arms 252 and 254 of handle 250 are urged toward oneanother to an extent selected by the user, thereby moving intermediatetubular member 236 distally relative to outer tubular member 242 andcausing the ends of curved cartridge arms 240 to move the locking/tyingmember distally so as to accomplish the suture tying function at adesired level of suture tension. Once the suture tying function has beencompleted to a desired level of tension, the handle 250 is released andthe applicator is maneuvered so as to allow the tied suture tie deviceto be released from the applicator 226. Since a plurality of suture tiedevices are preferably supplied in the cartridge, continuous (i.e.,sequential and uninterrupted) suturing procedures can be accomplishedwithout withdrawing the applicator from the surgical suture site.

FIGS. 27 and 28 illustrate an applicator 286 that represents amodification of the applicator 226 depicted in FIG. 25, in which similarcomponents have been provided with identical reference numbers. As shownin FIG. 28, an inner cartridge tubular member 272 is provided having acurved distal end 274. As an alternative to the curved spring member 258of FIG. 25, a spring-loaded cylinder 255 is provided which extendsproximally from collar 238 to a shoulder 257 which is positionedadjacent to shoulder 273 of the inner cartridge tubular member 272 andhouses a coiled spring 290 or other suitable biasing means. The cylinder255 functions in a manner similar to the curved spring member 258 ofapplicator 226 by providing a means for displacing the inner andintermediate tubular members together distally. It will be appreciated,therefore, that the respective cylinder 255 and spring member 258configurations can be interchangeable for applicators 226 and 286.

Illustrated in FIG. 29 is an applicator 262 that represents a furthermodification of the applicator 226 depicted in FIG. 25 that isparticularly useful for adjusting the separation distance between thecurved distal portion of various tubular member configurations forsevering or manipulating protruding proximal portions of suture tiedevices after suturing and tying. Throughout the following discussion ofapplicator 226, parts thereof which correspond to parts of applicator262 are identified by like reference numerals and are not repetitivelydescribed. The spacing adjustment mechanism of applicator 262 isprovided to control the spacing between the ends of curved arms 240 ofthe intermediate tubular member 236. The spacing adjustment mechanism266 includes a threaded rod 268 having an end secured to the distalportion of curved spring member 258 adjacent collar 238. The rod 268extends through a passage 258a formed in the proximal portion of spring256 to protrude therefrom and threadably receive an adjustment nut 270.

Operation of the applicator 262 is implemented by squeezing the handgrip260 relative to arm 254 of handle 250, thereby advancing the distal-mostsuture tie device into position in the cradle 246 in the mannerdescribed above with respect to applicator 226. The curved arms 240return to their locking/tying member-pushing position when the grip 260is released. Suturing can be accomplished in a manner similar to thatobtained from use of a conventional curved suture needle, in which thetissue is penetrated by a curved insertion motion of the distal end ofthe applicator 262. Rigid tethers 264 connect the distal end 234 of thecartridge tubular member 230 with the distal end 240 of the intermediatetubular member. Distal and proximal movement of the cartridge tubularmember 230 effects approximation and withdrawal, respectively, of thedistal tips 271 by way of the tethers 264. Following tissue penetrationby one or both of the cradle 246 and suture tie device, nut 270 of thespacing adjustment mechanism can be rotatably adjusted until it reachesthe proximal end of the threaded rod 268, thereby urging distal curvedarms 240 towards one another to position the distal ends 271 thereof inclose proximity to one another to, for example, grasp the end of thelength of suture material, abut the proximal end of the plug of a suturetie device, or to grasp and/or sever the proximal portion of any othervarious type of suture tie device such as those shown in FIGS. 1-20.With the distal ends 271 thus positioned, the handle arms 252 and 254can be grasped and squeezed toward one another such that the distal ends271 can, for example, push the length of suture material distally towardthe tissue penetrating leg 150 in instances where the suture tie device148 of FIG. 18 is utilized. Following the completion of any adjustmentto the relative spatial arrangement of the distal ends 271, the nut 270is rotated back to its rest position to open the distal ends 271 andreturn them to their locking/tying member-pushing position. Handle 250can then be squeezed further together to advance the locking/tyingmember distally to complete the tying operation. Once the tyingoperation has been completed, the handle is released and the tied suturetie device can be released from the applicator 262.

A further alternative arrangement for an applicator 277 that is amodification of applicator 262 of FIG. 29 is illustrated in FIG. 30,where parts of applicator 277 identical to parts of applicator 262 areprovided with identical reference numbers. Applicator 277 issubstantially similar to applicator 262, with the exception thatapplicator 277 includes a means 269' for positioning the curved distalend of the distal portions of the inner and intermediate members at adesired position for any severing, compressing, or manipulating actionthat may be required incident to the handling of a particularconfiguration and type of suture tie device used therewith. Thepositioning means 269' includes a rod 278 having a proximal endrotatably mounted to handle arm 254, a finger grip 280 at the distal endof the rod, and angled teeth 282 protruding from the rod along thelength thereof. The rod 278 extends through an opening 279 formed in arm252 of the handle and is operable in cooperation therewith to lock theposition of the handle arms 252 and 254 in a predetermined spatialrelationship. In use, the rod 278 can be rotated and locked in positionto allow precise positioning of the distal ends 271 of the curved arms240 of the tubular member 236 prior to the aforedescribed severingoperation. Once a suture tie device has been advanced distally into thecradle 246, as by grasping and squeezing toward one another grip 260 andhandle arm 254, the tissue or organ structure can be penetrated by atleast one of the distal ends of the suture tie device and cradle.Following penetration of the tissue or organ structure to be sutured,the handle 250 can be squeezed to direct movement of cartridge arms 240to move the locking/tying member distally to accomplish the tyingfunction. After tying, the handle 250 can be manipulated so as toposition the distal ends 271 along the proximal portion of the suturetie device to the desired position for severing the proximal portion ofthe suture tie device, and the position of the handle 250 can be fixedby rotatably adjusting the position of the rod 278 so that the teeth 282can engage the handle opening 279. The nut 270 of the spacing adjustmentmechanism 266' can be rotated until it abuts ring handle 284, therebydirecting rigid tethers 264 to pull arms 240 together to sever theproximal portion of the suture tie device at the desired point.Thereafter, the rod 278 can be released, and the screw 270 moved back toits rest position to permit the tied suture tie device to be releasedfrom the applicator.

As mentioned above, there are various configurations for the distalportions of the inner and intermediate tubular members which can beutilized with the applicators discussed above for applying the varioussuture tie devices of FIGS. 1-20. For example, FIG. 31 shows the innertubular member 272 as having a distal curved portion 274 that isprovided with sharp severing ends 273, and the intermediate tubularmember 276 as having a blunt distal end. The distal portion 274 can beprovided with a variety of configurations as well so as to accommodatethe structure of the specific suture tie device to be used. FIG. 32shows a distal face 240' for pushing the locking/tying members of a widevariety of the various suture tie devices shown in FIGS. 1-20. Thedistal face includes an indented portion 241' which can be provided witha sharp severing edge for severing the proximal portion of the legsafter the tying process is complete. FIG. 33 shows the distal face 240"which is arranged to push the locking/tying member specifically ofsuture tie device 148 after distal face indentations 241" engage andadvance the suture material 154 or 154' distally to circulate throughthe leg 150 of the device 148. These indentations 241" can also beprovided with a sharp edge for severing the protruding proximal portionof the suture material. The central indentation 241' can include asevering edge which allows the configuration of FIG. 33 to also be usedwith various other suture tie devices of FIGS. 1-20.

FIG. 35 illustrates an arrangement in which an inner tubular member 230'is provided with a straight distal portion with longitudinal slots 265'for allowing the distal and proximal movement of the curved distalportions 240' of intermediate tubular member 236'. As the inner member230' moves proximally, the distal tips 271', if sharpened, provide asevering action, and if blunt, provide a grasping, manipulating and/orcompressing action. The distal blunt ends 233' can be positionedspecifically for the suture tie devices of FIGS. 16-20. Indentations 231can be shaped to accommodate either the curved needle portion of thevarious suture tie devices or the various locking/tying members, and canbe disposed along the inner surface of the innermost tubular member ofany of the configurations described for the various applicators. Theseindentations can function in a manner analogous to the guides 224depicted in FIGS. 24B and 24C to hold and space apart accordingly thesuture tie devices within the cartridge.

With reference to FIGS. 36A and 36B, there is depicted a multiple legsuture tie device 300 in accordance with a further aspect of the presentinvention. The suture tie device 300 is comprised of at least twogenerally opposed and elongated tissue engaging or penetrating legs 302and 304 and a locking/tying member 308 which at least partiallysurrounds at least one, and preferably all, of the legs 302 and 304. Thelegs 302 and 304 are preferably joined at their respective proximal endsat a common proximal base 306 to facilitate handling of the device 300.The multiple-leg suture tie devices can be partially or entirely made ofentirely or partially bioabsorbable or non-bioabsorbable material, as isthe case of their single leg counterparts discussed above, and can alsobe provided with appropriate physical characteristics in accordance withtheir intended utilization and site of application. For example, eitheror both of the locking/tying member 308 and legs 302 and 304 can beconfigured so as to be entirely or partially rigid, semi-rigid,flexible, elastic, resilient, or malleable. The distal ends 400a and402a of the legs 302, 304 are configured so as to interlock with oneanother or abut against one another in close proximity and arepreferably angled or curved toward one another to facilitate suture tiedevice closure in the manner described below. Appropriate interlockingmeans can be provided along one or both of the legs to interlock thelegs incident to suture loop formation. For example, leg 302 can beprovided with a hollow female-like tubular distal end 400a having a boreor lumen 401a formed therein to receive the probe-like male distal end402a of leg 304. This hollow end can be provided with a sharp or bluntedge, and can be provided with a substantially closed, generally annularcross-sectional configuration. A plurality of perforations or holes 321extending through the wall at the distal end of leg 302 can be providedto communicate with lumen 401a. The distal end 402a of leg 304 defines atissue-penetrating male member adapted to be received in the hollowdistal end 400a of leg 302 such that locking protrusions 323 such asknobular extensions or ridges of distal end 402a can extend intoperforations 321 of distal end 400a to lock the male probe member withinthe female tubular member. The configurations of the leg interlockingmeans described above can be replaced with any other suitableconfiguration that ensures secure engagement of the leg members upon legengagement. It is to be appreciated that the legs of suture tie device300 can be provided with a greater or lesser degree of curvature thanthat depicted in FIG. 36A, as illustrated in the further suture tiedevice arrangements depicted in the drawings and discussed below.

The locking/tying member 308 of the device 300 defines a central lumenor passage 310 through which the legs extend. The interior of thecentral lumen 310 is configured with appropriately sized recesses ordeformable walls to accommodate the curvature of the distal portion oflegs 302 and 304 when the locking/tying member is advanced in the distaldirection following superposition or interlocking of the distal ends400a and 402a to create a suture loop. Alternatively, one or both of thelegs can be moved toward the other leg by distal advancement of thelocking/tying member 308 over the exterior surface of at least one ofthe legs 302 and 304. The locking/tying member 308 can optionally beprovided with internal coupling means 309a such as angled teeth (FIG.36B) along the interior surface of the central passageway 310 forcooperating with complementary means 339b such as a plurality of angledteeth or barbs protruding from the outer surface of the legs 302 and 304for providing selective displaceability of the locking/tying member 308in a predetermined single (distal) toward the distal ends 400a and 402aof legs 302 and 304, respectively. Other suitable coupling means can besubstituted for the arrangement of complementary angled teeth 339a and339b to provide the desired control over the direction of movement ofthe locking/tying member in relation to the legs of the device, examplesof which means include whisker-like filaments, ridges, angled pins, andmicroholes, all of which can provide for one-way displaceability of thelocking/tying member and can be disposed along all or part of the entiresurface of one or more of the legs and the lumen of the locking/tyingmember. The locking/tying member directional displacement controllingmeans 339b, such as the array of angled teeth or barbs depicted in FIG.36B, can be replaced by radially-extending filaments or other suitablemeans which allows for bi-directional displacement of the locking/tyingmember 308 along the legs 302 and 304. Such a bi-directional enablingarrangement can be advantageous in certain surgical procedures where itwould be desirable to permit the suture tie device user to loosentension in the suture loop in the event that the tissue or organstructure interposed between the legs 302 and 304 has been inadvertentlyover-tensioned by manipulation of the locking/tying member distally inexcess of the distance necessary to provide optimal suture loop tension.

In use, the suture tie device 300 is preferably mounted in a needle-likeor forcep-like member of an applicator similar to that disclosed in theabove-mentioned patent application, Ser. No. 049,504, and to those shownin FIGS. 52, 53 an 61 herein, and the suture tie device is manipulatedin a manner similar to that associated with manipulation of aconventional suture needle. That is, one or more of the needle pointsformed by the distal ends 402a and/or 400a is maneuvered to cause thetips thereof to penetrate sections of tissue to be sutured. Penetrationof the tissue can be accomplished by a single tip entering at least oneof the tissue sections first, or by all of the tissue sections beingpenetrated substantially simultaneously, or can be accomplished by thedistal tips of the applicator in the manner described below. Once thesuturing penetration maneuver is completed, the applicator can beoperated to move penetrating legs 302 and 304 relative to each other tocause the male member formed by the tip 402a to be received within thefemale member formed by distal hollow end 400a and locked therein due tothe engagement of protrusions 323 with holes 321. Alternatively, thetissue to be secured by the suture tie device can be sutured by movementof one or both of the legs 302, 304 toward the other such that therespective leg tips 400a, 402a are brought into opposition with oneanother so as to abut against one another or nearly contact one anotherwith a relatively small separation space therebetween. The locking/tyingmember 308 can then be moved distally along the legs 302 and 304 tocreate a desired tension in the suture loop formed by interlocking onapproximation of the legs 302 and 304. That is, the locking/tying member308 operates in a substantially similar fashion as a knot tied in aconventional length of suture material and can thus be moved along thepenetrating legs 302 and 304 to variable positions in accordance withthe desire of the surgeon to variably compress the tissue together bycontrolling the tension on the suture loop formed by the penetratinglegs and the locking/tying member. Once the locking/tying member isproperly positioned, the portion of the suture tie device 300 extendingproximally beyond the locking/tying member can be severed at a desirableposition and, if formed from a bioabsorbable material, can be left atthe surgical site to be absorbed by the body. Interlocking of the distalends of the penetrating legs 302 and 304, in combination with theflexibility of the legs, allows the suture tie device 300 to liesubstantially flat against the sutured tissue without disengaging.Accordingly, it will be appreciated that the suture tie device 300utilized with the applicator permits relatively simple and expedientsequential suturing of tissue, as shown in FIGS. 50A through 50C duringopen or closed (endoscopic) surgical procedures, thus substantiallyreducing the time required for the completion of such procedures andallowing for the use of endoscopic instrumentation in instances where itotherwise may not have been feasible.

A further embodiment of a suture tie device according to the presentinvention is illustrated in FIG. 37, wherein a plurality of elongatetissue approximating or penetrating legs 332, 334, 336 and 338 areprovided which extend from a proximal end 340 of the suture tie device330. The legs are preferably arranged in opposed pairs, although anuneven number of legs can be provided, and the legs can be independentlyor simultaneously manipulated in accordance with the intended use of thesuture tie device. The multiple leg suture tie device 330 can beutilized for various procedures, such as closing anatomical lumens orfor joining multiple separated sections of tissue, and can be utilizedin an applicator having a plurality of forcep-like or needle-likemembers equal in number to the number of tissue approximating orpenetrating. Operation of the device 330 is similar to that describedabove in connection with application of the device 300. Once the distalends of the legs have been moved to the desired positions, thelocking/tying member 308 is moved distally to tension the suture loopsformed by each pair of opposed suture legs, thereby causing theanatomical lumen to be reduced in diameter or closed off. As is the casewith the suture tie device 300 described above, the distal ends of thepenetrating legs of the multi-legged device 330 can be provided with awide variety of configurations to allow approximation or interlockingthereof as depicted in FIGS. 43A through 43F, and can be provided with aplurality of angled teeth or barbs 327 for engaging a conical orcylindrical bore 310 formed in the locking/tying member 308 to permitmovement of the locking/tying member in only the distal direction towardthe distal ends of the legs. It will be appreciated that the couplingmeans 339 for controlling movement of the locking/tying member along therespective device legs can vary as described above for all suture tiedevices, whether they have single, double, or multiple-legs. Once thelocking/tying member 308 has been moved to produce the desired tensionin the suture loops formed by the two opposed pairs of legs, theprotruding proximal portion of the suture tie device 330 can be severedas described above.

A further alternative aspect of the multiple leg suture tie deviceaccording to the present invention is illustrated in FIG. 38, in whichthe suture tie device 350 is provided with distal portions 368 and 370of legs 352 and 354, respectively, which are relatively sharply curvedso as to create a generally circular cylindrical space for retaining asegment of tissue therein. The curved portions 368 and 370 of the legs352 and 354 are preferably angled with respect to the proximal portionof the legs so that the distal tips extend generally transverselytherefrom and are accommodated by recesses 374 and 378 formed within thelocking/tying member 372. As described above, coupling means 339 such asridges or barbs can be provided along the length of the legs 352 and 354and within the passage 310 of the locking/tying member 308 to allow onlyfor the distal movement of the locking/tying member therealong. Theconfiguration for the interlocking means of the distal ends can vary asshown in FIGS. 43A through 43F and described below. The suturingprocedure for use of the device 350 is substantially similar to thatdescribed above for suture tie device 300.

FIG. 39 illustrates a further modification of a suture tie deviceaccording to the present invention, in which the suture tie device 410is provided with tissue penetrating legs 412 and 414 which are generallyrectilinear in configuration and can optionally be provided withslightly umbilicated spaces at their distal portions for suturingadditional quantities of tissue. The angled distal ends can beespecially useful for tubal ligation, vasoligation, or ligation for anyother floating or unfixed tubular structure. Male and female distalportions 415 and 417 extend generally transversely from penetrating legs412 and 414, respectively, with the distal end 415 defining a cavity orrecess 419 having a plurality of ribs 365 formed therein to co-act withfrusto-conical protrusions 327 formed on the distal end 421 of theopposed leg 414 to lock the distal end 421 within the cavity 419 of thedistal end 415. As noted previously, the female member can also beprovided with a sharp edge to penetrate the tissue substantiallysimultaneously with the male member upon manipulation of the legs towardone another. It is to be appreciated that the configurations of both thelegs of the suture tie device and their respective distal ends can bevaried in accordance with the type of tissue to be sutured and thelocation of the suture site within the body of the patient.

A further modification of a suture tie device of the present inventionis illustrated by suture tie device 430 in FIG. 40. In contrast to thestructure and manner of intended operation of the suture tie device 410,the penetrating leg 432 is arranged to be stationary, with onlypenetrating leg 432 being displaceable by the applicator to interlockthe distal ends 400c and 402c. An indentation or score line 433 can beprovided along leg 432 to facilitate folding of the leg towardstationary leg 434. The proximal portion of the legs can terminate at acommon base 306, or they can be arranged as separate, discrete membersthroughout their length, as can be the case with any of the multiple-legsuture tie devices described above and depicted in FIGS. 36A through 39.The open female member distal end 415' is provided with a plurality ofinternal ribs 459 (depicted in phantom) to interlock with frusto-conicalprotrusions 327 of the male member distal end 417' and a passage 419'having a slot 453 formed therein to receive the male member distal end.An aperture 451 is formed at the leg bend 438 of the distal end 400a toreceive therethrough the sharp tip of the distal end 402c of the malemember 417' incident to interlocking of the legs 432 and 434. Followingleg interlocking, locking/tying member 308 can be advanced distally toobtain a desired degree of tension in the suture loop in the mannerdescribed above.

FIG. 41 illustrates a suture tie device 470 which illustrates a furthervariation of a suture tie device in accordance with the presentinvention, and particularly the single displaceable leg arrangementdepicted in FIG. 40 and discussed above. Displaceable leg 472 isarranged to be received in an appropriately-dimensioned channel 511forward in the opposed stationary leg 474. The leg 472 is sharply angledat bend 478 to form a distal end 415'' that extends generallytransversely from the leg. The distal end 402d is provided with aplurality of outwardly-extending ribs or ridges 459' along its distalsurface that are adapted to be received by correspondingly-dimensionedrecesses 461 formed in the distal surface of the distal end 417'' of thestationary leg 474. The tips 400d and 402q of the distal ends 415'' and417'' can be provided with sharp edges to facilitate tissue piercing.Additionally, the stationary leg 474 is preferably provided with arecess 455 formed adjacent the bend 480 for receiving therein tissuethat is interposed between the legs 472 and 474. Preferably, thestationary leg 474 is provided with a plurality of slots or grooves 505along the length of the leg to embrace corresponding protruding members473 (FIG. 42) such as ridges, teeth or barbs formed along the leg 472when the leg 472 is urged into cavity 511. The proximal end of leg 474terminates in a sleeve 482 which is provided with a lumen 484 toaccommodate the proximal portion 476 of leg 472. The arrangement ofmutually engageable leg protruding members 473 and grooves 505 isprovided in lieu of a displaceable locking/tying member as analternative means for adjusting tension in the suture loop created byapproximation or engagement the distal ends of the respective legs 472and 474. The desired degree of tension in the suture loop can beobtained by engaging an appropriate number of corresponding legprotruding members and grooves upon pivotable displacement of leg 472with respect to leg 474.

Various modifications of distal end configurations for use with thesuture tie devices depicted in Figs. 36A through 38 and described aboveare illustrated in FIGS. 43A through 43F, in which similar componentsare identified by like reference characters. It is to be understood,however, that the illustrated modifications are merely exemplary of themyriad of possible distal end configurations and that the specificconfiguration utilized with a suture tie device will depend upon thetype and location of tissue to be sutured, extent of the manipulationrequired to effect suturing, and the preference of individual surgeons.In accordance with the type of tissue for which the suture tie device isto be utilized and the objectives of the surgical procedure, the distalends of the device can be configured so as to interlock, engage, orsimply to approximate one another, the distal ends can be or arrangedsuch that one end is received within the distal end of the other leg.The distal tip of one or both of the mutually cooperable distal ends canbe configured as a sharp, tissue-penetrating distal end, whereas theother of the distal ends can be configured as a blunt end.Alternatively, both mutually cooperable distal ends can be configured asblunt ends, as may be desirable when the distal ends are to bepositioned in close proximity to one another but not engage orinterlock. It shall be appreciated that depending on which suture tiedevice is utilized, the distal ends will be shaped accordingly.

With reference to FIG. 43A, the distal end 402a of the leg 304a isprovided with a sharp tissue-penetrating distal edge and includes aplurality of protrusions 323. The distal end 400a of leg 302a isconfigured to be received within a bore or lumen 401a of a female distalend 400a, which is provided with a plurality of the perforations 321 forlocking engagement with the protrusions 323 of the male member 402a uponinsertion of the distal end 402a therein.

With reference to FIG. 43B, a sharp male distal end 402b of leg 304b isprovided with a plurality of conical protrusions 327 and is arranged tobe received within the lumen 401b of the female distal end 400b of leg302b. The interior surface of the lumen 401b is provided with aplurality of rib-like protrusions 325 which extend into the lumen 401bto interlock with the conical protrusions 327 of the male member.

FIG. 43C illustrates a distal end arrangement in which a sharp maledistal end 402e is provided that includes an arrangement of conicalprotrusions 327. The female distal end 400e defines an undersized cavity401e and is split by a generally V-shaped slot 403 into a pair ofopposed, longitudinal portions 404e and 405e having a plurality ofinwardly-extending ridges or protrusions 325 formed along the respectiveinterior surface. Separation of the female distal end 400e intolongitudinally opposed sections in the manner described above providesthe distal end 400e with a spring-like bias to permit receipt of themale member 402e. The inwardly-extending ridges or protrusions 325 ofthe female member 400e can interlock with ridge-like protrusions 327formed along the exterior of the male member. The provision of aspring-biased female member and the arrangement of interlockingprotrusions 325 and 327 carried by the respective female and malemembers ensures secure interlocking engagement of the distal ends of thesuture tie device.

FIGS. 43D and 43E illustrate arrangements for suture tie device distalends in which the distal ends are to be positioned in close proximitywith one another but not physically engage or interlock. With respect tothe arrangement depicted in FIG. 43D, the distal ends 400f and 402f oflegs 302f and 304f, respectively, are arranged so as to be positionablein a generally parallel orientation that is generally parallel to thelongitudinal axis of the suture tie device. At least one of the distalends, such as distal end 402f, can be provided with a plurality ofjagged teeth 403f to facilitate tissue penetration. FIG. 43E illustratesan arrangement similar to that depicted in FIG. 43D, with the exceptionthat the distal ends 400g and 402g are positionable generally parallelto one another along a plane that extends generally non-transversely ofthe ends of corresponding legs 302g and 304g. It will be appreciatedthat one or more of the pairs of distal ends 400f, 402f and 400g, 402gcan be configured as sharp or blunt ends, and can be configured asgenerally planar ends as shown, or as non-planar, jagged sharp or bluntends in accordance with such factors as the type of tissue to be suturedand the preference of the user.

FIG. 43F illustrates a distal end arrangement in which the distal end400h of leg 300h defines a lumen 401h that is dimensioned to receive innon-interlocking fashion the solid distal end 402h of opposed leg 304h.Mechanical interlocking means such as ridges, barbs, slots and otherarrangements as discussed above are not provided with either of thedistal ends of this arrangement. Instead, the legs 302h and 304h of thesuture tie device are secured in position by receipt of the distal endof one of the legs within the lumen defined by the other of the opposedpair of legs.

Further modifications of the distal end configurations for useparticularly with suture tie devices depicted in FIGS. 39 through 41 areillustrated in FIGS. 44A through 45D, the illustrated modificationsbeing exemplary and not limiting. With reference to FIG. 44A, the maledistal end 415'a terminates at a sharp distal tip 419'a and includes aplurality of conical protrusions 327 formed along its exterior surface.The distal end 417'a of the opposed leg is curved so as to extendproximally and terminate at a sharp distal tip 540a. An aperture 541a isprovided adjacent the tip 540a that is dimensioned to receive, andoptionally engage, the distal end 415'a and the conical protrusions 327carried thereby. Interlocking protrusions (not shown) such as theprotrusions 325 depicted on FIG. 43B and described above can optionallybe provided along the interior surface of the aperture 541a.

FIG. 44B illustrates a distal end arrangement in which the sharp maledistal end 415'b extends from the leg so as to define an acute includedangle α and is provided with a plurality of angled or conicalprotrusions 327. The distal end 415'b is configured so as to be receivedwithin a recess 541b formed in the opposed female distal end 417'b. Thefemale distal end 41'b includes a plurality of barbs or ridges 365formed along the interior of the recess 541b to interlock withprotrusions 327 of the male member 415'b. The barbs or ridges 365 arepreferably arranged in opposed rows, as shown in the drawing, althoughother configurations can be provided. Shoulders 418 and 420 are providedadjacent the distal ends of the respective legs 432 and 434 are providedto inhibit distal movement of the locking/tying member beyond the distalends of the suture tie device.

Further distal end configurations for the legs of the various suture tiedevices depicted in FIGS. 36 through 41, and most notably FIGS. 40 and41, are depicted in FIGS. 45A through 45D. With reference to FIGS. 45Aand 45B, there is depicted a leg distal end arrangement 550a in whichthe lower leg 434, which can either be fixedly positioned or movablymounted to the proximal end of the suture tie device, is provided with acurved configuration which terminates at a proximally-extending sharptip 554a. The lower leg 434 can optionally be provided with a recess 455adjacent the curve distal end for accommodating tissue sutured by thesuture tie device. The distal end 552a of the opposed leg 432 terminatesat a sharpened tip 556a that is curved so as to extend beyond thedistal-most edge of the distal end 550a. A slotted aperture 501 isprovided adjacent distal end 552 along arm 432 to receive the curveddistal end 550a of the opposed arm 434 therethrough.

FIG. 45C depicts a distal end arrangement in which a male distal end552b of one of the legs of the suture tie device, such as leg 432, isprovided with a sharp distal tip 556b and an inwardly-extending notch orrecess 503 formed along the distal edge of the end 552b. Opposed femaledistal end 550b of leg 434 is configured so as to curve toward the maledistal end 552b and terminates at a sharp tip 554b. The distal end 550bincludes an aperture 555 formed along the associated leg of the suturedevice that is appropriately dimensioned to provide for an interlockingengagement with the recess 503 of the opposed distal end 552b.

FIG. 45D depicts a further distal end arrangement in which the distalend of one of the legs, such as distal end 552c of leg 432, is providedwith an outwardly-extending protruding member 505, and the distal end550c of the other leg 434 is provided with a plurality of alignedrecesses 503, each of which is dimensioned to receive the protrudingmember 505 of the opposed leg 432. Tissue receiving recess 455 asdescribed above can optionally be provided along the leg 434, as shownin the drawing. The arrangement of recesses 503 allows the suture tiedevice to be used in conjunction with a relatively wide variety oftissue thicknesses, as engagement of the protruding member 505 with aselected one of the plurality of recesses permits the user to select theappropriate extent of distal end engagement that may be desirable for aparticular utilization of the suture tie device. Whereas the depicteddistal end arrangement provides for the protruding member to bepositioned along the distal side of the distal end 552c and for theplurality of recesses 503 to be positioned along the proximal side ofdistal end 550c, it is to be appreciated that the placement of theprotruding member and recesses could be reversed from that depicted.Additionally, the respective distal end configurations could be reversedfrom that shown in FIG. 45D, such that distal end 552c is provided onleg 434 and distal end 550c is provided on leg 432.

Details of specific configurations for the surfaces of the legs of thevarious suture tie devices described above are depicted in FIGS. 46 and47 for coupling with the corresponding surface of an opposed leg or withthe interior luminal surface of the associated locking/tying member.With reference to FIG. 46, the inwardly-facing surfaces of each leg,such as leg 304, can be provided with a plurality of ribs 562 andgrooves 563 arranged in an alternating configuration to facilitatemating cooperation and locking between the legs of the suture tie devicewhen the leg surfaces are superposed over one another upon distalmovement of the locking/tying member. The ribs 562 and grooves 563 canbe oriented so as to extend longitudinally along the length of the legs.Alternatively, the ribs and grooves can be oriented in any of a varietyof configurations, such as laterally or angularly extending with respectto the longitudinal axis of the leg, with the ribs and grooves on theother leg having a corresponding configuration to facilitate matingthereof.

FIG. 47 illustrates an enlarged segment of a leg of a suture tie device410 as described above in connection with FIG. 39 illustrating oneconfiguration of the coupling means 339b in which a plurality of ridges560 are formed within a longitudinal groove 564 which extends along thelength of the leg. The ridges 560 are configured to couple with acorresponding internal luminal configuration 339a of the locking/tyingmember 308 to provide the desired degree of uni- or bi-directionalcontrol of locking/tying member displacement along the respective legsof the suture tie device.

FIGS. 48A and 48B illustrative the use of a suture tie device of thesubject invention, such as the device 300 depicted in FIG. 36, forocclusion of an anatomical tubular organ structure such as a Fallopiantube or vascular member 282. Because of the curved configuration of thelegs 302 and 304, the suture tie device 300 can easily be utilized withcomparatively large tubular members by virtue of the adjustability incapacity and size for the suture loop that can be created by the device300. As shown in FIG. 48A, the suture tie device 300 can be manipulatedby an appropriate applicator (not shown) so as to position the tubularmember 282 between the opposed legs 302 and 304 of the device. One ormore of the sharp distal ends 400b and/or 402b of the legs 302 and 304can be manipulated to penetrate the tubular member supporting membrane280, after which the leg distal ends can be displaced relative to oneanother so as to approximate, engage or interlock in the mannerdescribed above to form the suture loop, designated generally byreference character L. Leg approximation, engagement or interlocking canbe accomplished by either displacing one or both of the opposed legstoward the other as described above and then distally advancing thelocking/tying member to obtain the desired degree of tension in thesuture loop, or by distally advancing the locking/tying member in theabsence of any prior movement of the distal ends of the legs so as todisplace one or both of the opposed legs to approximate, engage orinterlock with the other. The position of the locking/tying member 308along the device legs 302 and 304 is maintained by the cooperation ofleg-engaging means 339a (FIG. 36B) provided along the lumen 310 of themember 308 and the arrangement of barbs/angled teeth 339b or othersuitable means, such as ribs 562 (FIG. 46) and ridges 560/grooves 564(FIG. 47). When the suture tie device 300 is formed entirely frombioabsorbable material, the suture loop L formed by the device 300 canremain in place until the device is absorbed into the tissue surroundingthe tubular member. It will be appreciated that the time period beforewhich absorption is completed can be varied in accordance with theselection of material used in the device and the dimensions andconfiguration of the device and all of its components. Excess suturematerial proximal of the locking/tying member 308 can be trimmed fromthe device 300 along the line "S", if so desired by the user.

FIGS. 49A through 49C illustrate use of a suture tie device 330A in itsrepresentative suturing stages as described above. The device 330A is amodification of the suture tie devices 300 and 330 described above, inwhich the suture tie device 330A is provided with two of the fouropposed legs of the device 330 shown in FIG. 37. With reference to FIG.49A, the segments of tissue 284 and 286 are penetrated by either one orboth leg distal ends 400b and 402b with or without the assistance of theforcep-like or needle-like members of the applicator described below,and the distal ends are moved toward one another so as to interlock.Interlocking of the distal ends of the legs, as shown in FIG. 49B,permits the tissue segments to be joined and further sutured by thetying of the suture loop by way of distal movement of the locking/tyingmember 308. Following appropriate tensioning of the suture loop L bymovement of the locking/tying member distally along the legs 332 and336, as illustrated by the arrows. In a preferred aspect of theinvention, the entire suture tie device 330A is in FIGS. 49A and 49B,the protruding proximal portion of the suture tie device can be severedat a desired position, as indicated by the dotted-line S of FIG. 49B,and removed from the surgical site to provide a neatly trimmed sutureloop L (FIG. 49C) at the suture site. Tensioning of the suture loop Lcan result in a slight bending of the leg distal ends in a proximaldirection toward the locking/tying member, thereby further securing thetissue segments 284 and 286 within the suture loop L formed from asuitable bioabsorbable material in order to permit the suture loop andany severed portions of the suture tie device to remain at the surgicalsite to be absorbed by the tissue.

The suture tie devices of the subject invention can also be used toclose or substantially close a tissue aperture, as noted above. Themulti-leg pair suture tie device 330 of FIG. 37 is most advantageouslyused for aperture closing. With reference to FIG. 50, the distal ends400b, 400b and 402b and 402b of the legs 332, 334, 336 and 338 arepositioned adjacent the aperture "A" in tissue segment 285 and areextended into the tissue segment. The distal ends of the respective legpairs can optionally be interlocked with one another. Followingpenetration of the tissue segment 285 by the legs, the locking/tyingmember is distally advanced in the manner described above to reduce thesize of the suture loops extending between each opposed leg pair and thelocking/tying member, thereby reducing the dimensions of the aperture"A".

While the foregoing description has described the use of the variousarrangements of suture tie devices for closed surgical procedures atsurgical sites typically remotely situated from the exterior surface ofthe body of a patient, it is nevertheless to be understood that thesuture tie devices of the present invention are likewise applicable foruse in subcuticular suturing to close an opening or wound in the skin ofa patient. Subcuticular suturing can be accomplished by manipulating oneor more suture tie devices of the subject invention so as to penetrateonly the subcutaneous layer of the skin to close or substantially closethe wound or opening with a minimal amount of contamination to decreasethe incidence of infection, facilitate healing, and minimize theformation of scar tissue. Depending on the location of the surgicalsite, various shapes and sizes of suture tie devices can be utilized. Itis to be further understood that both macro and micro-surgicalprocedures can be accomplished through the use of suture tie devices ofvarious dimensions and configurations of the subject invention.

With reference to FIG. 51, there are depicted further alternativeaspects of the suture tie devices of the subject invention and theirrespective operational sequences for effecting tissue approximation. Theillustrated suture tie devices 600 and 600' are in the form ofadjustably tensionable clip-like structures and can be formed from asurgical grade of stainless steel, titanium, or suitable bio-absorbablematerial. As shown in the drawing, the device 600 is comprised of agenerally elongate member that can be configured into a pair of opposedlegs 602 and 604 that are joined at their respective proximal ends atbend 606. The distal end 608 of the leg 602 terminates at a tip 610 thatis axially aligned with the principal (longitudinal) axis of the leg 602from which it extends. The tip 610 can optionally be provided with anarray of outwardly and longitudinally extending ribs 612, as shown at610', or the tip 610 can be provided with a plurality of outwardlyextending ribs 614 that extend generally transversely of thelongitudinal axis of the tip, as shown at 610". The opposed leg 604defines a generally U-shaped or C-shaped channel 616 (when viewed incross-section) that terminates at a closed-ended distal end 618. Thechannel 616 can be provided with a generally smooth interior surface, asshown at 616', or can be provided along its interior surface with aplurality of ridges or grooves 620 that extend generally transversely ofthe longitudinal axis of the leg, as depicted at 616''. Regardless ofthe interior configuration of the channel, the channel can beresiliently biased to resiliently receive and retain the opposed legmember in the manner described below. The distal end 618 is preferablyconfigured so as to bend toward the opposed leg 602 and terminate at asharp distal tip 622. Because of the curvature of the distal end 618,the distal end defines a recess or pocket 624 for receiving andretaining the distal tip 610 of the leg 602 upon engagement of therespective distal ends 608 and 618 in the manner described below.

Step B illustrates the initial step of closure of the device 600, inwhich closure is initiated by extending one or both of the distal endsthrough the tissue to be joined and applying a force in the direction ofthe arrows against the distal ends 608 and 618 along an acute includedangle with respect to the longitudinal mid-line M so as to bend therespective distal ends 608 and 618 toward one another so that the distaltip 610 of arm 602 is inserted within channel 616 of the leg 604 so asto engage with the distal end 618 of the leg 604. Once the respectivedistal ends have engaged one another in the manner described above,force is further applied to the respective exterior surfaces of the legs602 and 604 in a direction generally transverse of the mid-line M, asindicated by the arrows in the Step C, so as to urge the distal end 610into recess 624 of distal end 618. The distal end of the leg 604 can beconfigured with a sharp distal tip 622, as illustrated in Step A, or thedistal end can be provided with a generally rounded blunt end, asindicated at 618A. As is shown in the detailed illustration of thedistal end arrangement designated by reference character 618A, as forceis exerted generally transversely of the mid-line M, the distal tip 610of leg 602 is advanced distally within the closed recess 624 in thedirection of the arrow in phantom to securely interengage the tworespective distal tips 610 and 618. Further application of forcetransverse of the mid-line M brings the legs 602 and 604 into agenerally parallel, superposed orientation, as indicated at Step D, withtissue to be secured by the device 600 interposed between the legs 602and 604. Control of the application of force allows for tensioning ofthe suture loop L formed by the interengaged distal ends 608 and 618 andthe connected proximal leg ends to a level selected by the user.

With reference to steps A' and B', there is depicted a furtheralternative configuration for the suture tie device depicted in Steps Athrough D. Step A' illustrates a device 600' that is comprised of a pairof generally opposed legs 602' and 604' that are joined together attheir respective proximal ends at bend 606'. The leg 604 defines agenerally U-shaped or C-shaped channel 616 that can be configured in amanner analogous to that of channel 616 of the device 600. Tee distalend 608' of the leg 602' is curved toward the longitudinal mid-line Mand terminates at a distal tip 610. The distal end 618' is also curvedtoward the mid-line M, and defines a recess 624 that is continuous withthe channel 616 for receiving the distal tip 610. The distal end 618'terminates at a distal tip 622 that can be configured as a sharp tip forfacilitating tissue penetration, or as a blunt tip 618A. As force isexerted against the respective distal ends 608' and 618' along an acuteincluded angle relative to the mid-line M (Step B'), the distal tip 610is received within the channel 616. Thereafter, operation of the device600' is identical to that for the device 600 and follows the proceduredescribed above and illustrated in Steps C and D.

The suture tie devices 600 and 600' can be formed entirely from the samematerial, or they can be formed from different materials in accordancewith the objectives of the surgical procedure and the nature of thetissue to be sutured. For example, one or both of the device legs can beformed entirely or partially of a rigid or semi-rigid bioabsorbablematerial or from a non-bioabsorbable material such as titanium orsurgical grade stainless steel, such that one leg is entirely orpartially formed from one material, and the other leg is entirely orpartially formed from another material.

An applicator 1000 for applying the various double-leg suture tiedevices of FIGS. 36A through 39 according to the present invention isillustrated in FIGS. 52 and 53. The applicator includes an array ofthree concentrically-arranged tubular members: an inner cartridge member1010, an intermediate tubular member 1030, and an outer tubular member1050. The inner cartridge 1010 houses a plurality of suture tie devices,such as the devices 300 depicted in FIG. 53, which are disposed in anend-to-end fashion and are spring-biased distally by the force exertedby a spring member 1018 mounted within the cartridge member 1010. Thecartridge 1010 includes a tubular member 1012 having a cap 1020 (FIG.52) at its proximal end 1014 and an open distal end 1016. The distal end1016 of the tubular member is preferably configured with blunt edges andis arranged so as to be engageable by outlying curved arms 1036 and 1038of the intermediate tubular member 1030 by means such as tethers 1017and 1019 as shown in detail in FIG. 54. The spring member 1018 ismounted within the cartridge tubular member 1012 in compression betweenthe cartridge cap 1020 and a pusher member 1022 mounted at the distalend of the spring member 1018. The pusher member 1022 includes a recessformed therein to receive the proximal end of the last (i.e., mostproximally positioned) of the series of suture tie devices loaded withincartridge 1010.

The proximal end 1032 of the intermediate tubular member 1030 is securedto a collar 1034. Two or more expandable curved arms 1036 and 1036',1038 and 1038' (FIGS. 52 and 55) are provided at the distal end of thetubular member 1030 and can be configured with blunt or sharp distalends 1040 and 1040', 1042 and 1042', respectively. The intermediatetubular member 1030 is disposed between cartridge tubular member 1012and the outer tubular member 1050, which has a proximal end 1052 securedto collar 1054 and a distal end that terminates at two or more fixedneedles 1056 and 1058 (FIG. 53). The needles are preferably generallyU-shaped in cross section and have a configuration which can vary inshape in accordance with the curvature of the legs of the suture tiedevices, as illustrated in FIGS. 56 and 57 and the configuration of thedistal ends of the suture tie device legs. The needles 1056 and 1058terminate at sharp distal ends 1060 and 1062, respectively, which can beconfigured so as to provide for tissue cutting and penetration ininstances where the distal ends of the suture tie devices themselves arenot configured with sharp, tissue penetrating edges. Alternatively, thedistal ends 1060 and 1062 of the instrument 1000 can be configured asnon-sharpened ends in instances where the suture tie devices to beapplied by the instrument are provided with relatively sharp tissuepenetrating distal ends.

With reference to FIG. 58, collapsible guides 1063 can be provided alongthe interior wall of the outer tubular member 1050 adjacent to thecurved distal arms 1036 and 1038 (see FIGS. 52 and 54) of intermediatetubular member 1030. The guides 1063 extend distally toward the centerof the tubular 1050 to direct the distal-most suture tie device to aloading position between the needles 1056 and 1058. After one of thesuture tie devices has been loaded between the needles 1056 and 1058,the guides 1063 maintain the locking/tying member suture tie device atan appropriate position in order that the curved distal arms 1036 and1038 can be manipulated so as to urge the locking/tying member in thedistal direction to tie the suture loop.

The instrument 1000 can be provided with a generally U-shaped handle1064 which has a distal arm 1066 secured to a distal collar 1054, aproximal arm 1068 secured to an intermediate collar 1034, and a springbiasing member 1067 extending between the arms 1066 and 1068. A curvedspring member 1070 extends from intermediate collar 1034 to a proximalcollar 1024 secured to cartridge tubular member 1012 and includes afinger grip 1072 that extends downwardly from the proximal collar 1024.A spacing adjustment mechanism 1074 can be provided to control thespacing between the distal ends 1040 and 1042 of the curved arms 1036and 1038, respectively, between the generally closed position shown inFIG. 52 and the open position shown in FIG. 59. The spacing adjustmentmechanism includes a rod 1076 having a distal end secured to the distalportion of the curved spring member 1070 adjacent to collar 1034. Theproximal end of the rod 1076 extends through a passage 1071 formed inthe proximal portion of the spring member 1070 and terminates at anadjustment switch 1078. The adjustment switch includes a knob 1080pivotably mounted to the rod 1076 such that when the knob is in thevertical, upright position, the distal ends 1040 and 1042 of the tubularmember 1030 are adjusted such that they are in the position shown inFIG. 52 to move that proximal end of the suture tie device. When switch1078 is pivoted toward the distal end of the applicator such that theknob 1080 abuts the proximal portion of the spring member 1070, thedistal ends 1040 and 1042 are urged apart to the position shown in FIG.59 to permit passage of the locking/tying member distally past thedistal ends to tie the suture loop.

An alternative spacing adjustment mechanism 1074', as shown in FIG. 60,can be provided to allow for more precise control for the spacingbetween the distal ends 1040 and 1042 at any position between the openand generally closed positions depicted in FIGS. 52 and 59 for themanipulation or severing of the proximal portion of the suture tiedevice loaded between the needles 1056 and 1058. The mechanism 1074'includes a threaded rod 1076' having a proximal portion which threadablyreceives a correspondingly-threaded adjustment nut 1078 and thatterminates at its proximal end with a knob 1077. A mechanism 1081 forsevering the proximally-extending portion of the suture tie devicefollowing suture loop formation can optionally be provided. The severingmechanism 1081, the operation of which is described below, includes arod 1082 that is fixed at its distal end to the proximal arm 1068 of theU-shaped handle 1064 and that extends through a passage 1073 formed inthe arm of the grip 1084 adjacent shoulder 1024.

In use, a cartridge 1010 having a plurality of serially-arranged suturetie devices is loaded in applicator 1000 through the open proximal endof the intermediate tubular member 1030. In order to position thedistal-most suture tie device between the fixed needles 1056 and 1058,grip 1072 and proximal handle arm 1068 are squeezed together, therebymoving cartridge tubular member 1010 distally relative to theintermediate tubular member 1030 and causing distal end 1016 with itstethers 1017 and 1019 to open or expand distal arms 1036 and 1038 to theposition depicted in FIG. 59. The spring bias of spring member 1018mounted within the cartridge 1010 advances the distal-most suture tiedevice between needles 1056 and 1058 and beyond the expanded arms 1036and 1038, such that the locking/tying member of the suture tie device isheld in place by guides 1063. When the grip 1072 is released and theswitch 1078 is in its upright (rest) position (FIG. 52), the curved arms1036 and 1038 return to the position depicted in FIG. 52 due to the biasof the curved spring member 1070. With the suture tie device thuspositioned between the needles 1056 and 1058, the tissue or organstructure can be sutured by penetrating the tissue with either one orboth of the sharp distal ends 1060 and 1062 of the instrument needles1056 and 1058 and/or the legs of the suture tie device in a conventionalcurved, suture needle-like fashion such that the sutured tissue is heldbetween the needles 1056 and 1058. Following penetration of the tissue,arms 1066 and 1068 of the handle 1064 can be squeezed toward one anotherto move intermediate tubular member 1030 distally relative to outertubular member 1050, thereby causing the ends 1040 and 1042 of curvedarms 1036 and 1038 to push and advance the proximal end of the suturetie device distally to accomplish approximation, engagement orinterlocking of the distal ends of the suture tie device. The tyingfunction can be accomplished by pivoting switch 1078 completely to theleft such that its knob 1080 abuts against the proximal portion ofspring member 1070, thereby advancing tubular member 1012 slightlydistally such that the arms 1036 and 1038 are expanded to the positiondepicted in Fig. 59, thereby allowing the proximal portion of the suturetie device to enter between the ends 1040 and 1042, which ends arepositioned so as to push the locking/tying member in the distaldirection upon distal extension of tubular member 1030 to diminish thesize of the suture loop around the sutured tissue until the loop isultimately tied with the desired level of tension.

Once the tying function is completed to a desired tension level, theprotruding proximal portion of the suture tie device can optionally besevered at a desired length such that the tied loop remains intact. Toaccomplish this severing function, the space adjusting mechanism 1074'can be used to adjust the separation distance between the distal ends1040 and 1042 such that they can be positioned in close surroundingproximity with the protruding proximal portion of the suture tie device;thereafter, the arms 1066 and 1068 of handle 1064 can be squeezed towardone another such that both the cartridge tubular member 1012 and theintermediate tubular member 1030 are moved distally together to move thedistal ends 1040 and 1042 along the protruding proximal portion of thedevice until they reach the desired severing point. Thereafter, thegrips 1072 and 1084 are squeezed together such that the tethers 1017 and1019 of the tubular member 1012 pull the sharp distal ends 1040 and 1042toward one another to sever the proximal portion of the suture tiedevice. After the severing function is completed, the handle 1064 isreleased, thereby allowing for the release of the tied suture tie devicefrom the applicator 1000. As a plurality of suture tie devices can besupplied within the cartridge 1010, multiple suturing of organ andtissue structures can be accomplished without withdrawing the applicatorfrom the body, thereby greatly simplifying and expediting suturing andminimizing the time during which the patient is under anesthesia.

Another embodiment of a suture tie device applicator in accordance withthe subject invention is depicted in FIG. 61. The applicator, designatedin general by reference numeral 2000, includes a cartridge 2010 that isadapted to store a plurality of multiple leg suture tie devices of thetype discussed above. The suture tie devices are disposed within thecartridge 2010 in an end-to-end serial arrangement and are spring-biaseddistally by a spring member 2018 that is mounted in compression betweenproximal end cap 2020 an pusher member 2019 in a manner substantiallysimilar to that described above with respect to applicator 1000. The cap2020 can be permanently affixed to the cartridge 2010, or it can beremovably mounted thereto in a conventional manner, such as by mutualthreaded engagement with the proximal end of the cartridge, to permitfor cartridge reloading with additional and/or different types ofmultiple leg suture tie devices. The distal end 2016 of the cartridge isopen-ended. The cap 2020 has a neck 2021 which extends distally and isarranged to abut against or to be fixed to the proximal portion 2023 ofa hollow cylinder 2024. The cylinder 2024 houses a helical spring 2026that is disposed between the cylinder 2024 and the cartridge 2010 andthat is mounted in compression between a proximal collar 2034 of anoutlying forcep tubular member 2050 and the proximal cylinder portion2023. One or more slots 2025 is formed at the distal end of cylinder2024 to allow for distal and proximal movement therein of a proximalcollar 2084 of an outer tubular member 2080.

The proximal end 2032 of an intermediate tubular member 2030 is securedto collar 2034 and, at its distal end, is provided with at least onepair of curved, radially-expandable arms 2036 and 2038 which terminateat distal ends 2040 and 2042, as illustrated in side view in FIG. 62 andfrontally in FIG. 63. The intermediate tubular member 2030 is disposedbetween the cartridge tubular member 2010 and the forcep tubular member2050. The forcep tubular member 2050 includes a proximal end 2052 thatis positioned adjacent to collar 2034 of intermediate tubular member2030, a proximal portion that is secured to collar 2054, and a distalend which terminates at a forcep assembly 2055 that is comprised of atleast two opposed forcep members 2056 and 2058. Each of the forcepmembers is preferably C-shaped or U-shaped in cross-section and isconfigured so as to accommodate the configuration of the suture tiedevices utilized. At least one, and preferably both, of the forcepmembers terminates at a sharp distal end, such as ends 2060 and 2062depicted in FIG. 61. As described with respect to applicator 1000, thelength and configuration of the sharp ends 2060 and 2062 of the forcepscan vary in accordance with the suture tie device used, thereby allowingfor predetermined selection as to which one (or both) of the forcep endsfunctions as the tissue-penetrating member. In addition, theconfiguration of the distal ends may vary as shown in FIGS. 64A through64C and 65, wherein the distal end 2062' is received within distal end2060' (FIG. 64A), distal ends 2060" and 2062" meet at a slant (FIG.64B), distal ends 2060 and 2062 meet at pointed tips (FIG. 64C), or inwhich distal end 2060'" is displaceable relative to fixed distal end2062'" and received thereby. The configuration of the forceps 2056 and2058 in their entirety can vary in accordance with the configuration ofthe suture tie device utilized, as shown in FIGS. 66 and 67. Forexample, suture tie devices of the present invention of the typecomprising mutually displaceable legs, such as those depicted in FIGS.36 through 39, can be utilized in connection with an applicator 2000equipped with forceps 2056 and 2058 of FIG. 67, whereas the arrangementof movable and stationary legs of the suture tie devices of the presentinvention, such as those depicted in FIGS. 40 and 41, can be utilized inconnection with an applicator 2000 equipped with an arrangement ofmovable and stationary forceps 2056' and 2058', respectively, asillustrated in FIG. 65. Referring once again to FIG. 61, protrudinginwardly from the proximal portion of the forceps 2056 and 2058 is apair of opposed pins 2061 and 2063 which are preferably configured withsharp distal tips to permit penetration and grasping of the proximalportion of the suture tie device when the forceps are in their closedposition. The outer tubular member 2080 can optionally be provided witha slightly expanded proximal portion 2082 to limit the extent to whichthe applicator can be inserted within a portal or sleeve-like tubularmember such as a trocar sleeve.

With reference to FIGS. 68A and 68B, a pair of opposed longitudinalslots 2087 and 2089 is disposed along the outward length of the forceps2056 and 2058 to allow the distal and proximal movement of bilateralarms 2088 and 2090 of the outer tubular member 2080. The bilateral arms2088 and 2090 protrude distally and terminate at holding members 2092and 2094, which can vary in shape depending on the configuration of thelocking/tying member of the suture tie device, and which prevent thelocking/tying member from moving proximally as the forceps 2056 and 2058are retracted proximally in the manner described below incident tosuture tying. Also protruding from the distal end 2036 of the outertubular member is a pair of opposed retaining members 2096 and 2098which inhibit distal movement of the locking/tying member therepast.

The applicator 2000 includes a generally U-shaped handle 2064 formanipulating the various tubular members of the applicator 2000. Thehandle 2064 includes a distal arm 2066 secured to a collar 2054, aproximal arm 2068 secured to a collar 2084, a spring bias 2067connecting the two arms 2066 and 2068, and ring handles 2063 and 2065extending from the respective arms 2066 and 2068 to facilitate graspingof the handle. A rod 2070 secured at its distal end 2072 to distal arm2066 extends through a passage 2069 formed in the proximal arm 2068 andis secured at its proximal end 2074 to cap 2020.

In use, a cartridge 2010 with a plurality of multiple leg suture tiedevices serially arranged therein is loaded or pre-mounted withintubular member 2030 of the applicator 2000. In order to position thedistal-most suture tie device into the forceps 2056 and 2058, ringhandles 2063 and 2065 are spread apart, thereby moving forcep tubularmember 2050 distally to open the inwardly-tensioned forceps and movingcollar 2084 proximally through slots 2025 as it abuts and pushes collar2034 proximally to move intermediate tubular member 2030 in the proximaldirection. Upon movement of the handle arms in the aforedescribedmanner, cap 2020 and cartridge tubular member 2012 are displaceddistally by the rod 2070, ultimately causing blunt distal end 2016 ofthe cartridge tubular member 2010 to distally open or expand the curvedarms 2036 and 2038 and allowing the spring bias within the cartridge topush the distal-most suture tie device into the forceps 2056 and 2058past the expanded arms 2036 and 2038, as illustrated in FIG. 69. Whenthe ring handles 2063 and 2065 are released, the curved arms 2036 and2038 return to their normal (rest) position due to the bias of spring2026. With the suture tie device positioned in the forceps, the tissueor organ structure can be sutured by penetrating the tissue with eitheror both sharp distal ends of the forceps and/or the suture tie device ina conventional suture needle-like fashion.

Following penetration of the tissue, ring handles 2063 and 2065 aresqueezed toward one another, thereby moving forcep tubular member 2050distally relative to outer tubular member 2080 to substantially orcompletely close the forceps such that their distal ends 2060 and 2062approach or abut against one another to ensure the interlocking of thedistal ends of the suture tie device loaded within the forceps 2056 and2058. Once the forceps close together, the ends of pins 2061 and 2063pierce and grasp the proximal portion of the suture tie device. Afterthe distal ends of the forceps are displaced toward one another, thering handles are squeezed further toward one another, thereby displacingthe closed forceps proximally. Because the proximal portion of thesuture tie device is engaged by the forceps pins, the proximal suturetie device portion is pulled proximally as well; simultaneously, thelocking/tying member of the suture tie device is moved distally by theholding members 2092 and 2094 and the retaining members 2096 and 2098 ofthe outer tubular member 2080 to accomplish the tying function. Once thetying function is completed to a desired degree of suture knot tension,the handle 2067 is released, thereby allowing the tied suture tie deviceto be released from the applicator 2000. As a plurality of suture tiedevices are supplied within the cartridge 2010, multiple suture suturingprocedures can be accomplished without withdrawing the applicator 2000from the suture site.

From the foregoing detailed description, it will be appreciated that thesuture tie devices of the present invention allow tissue penetration andsuture tying in a manner that will be more familiar to surgeons thanthat provided by known devices. Accordingly, the time normally requiredfor suturing in both endoscopic and open surgery can be greatly reduced,in that no cumbersome, time-consuming manual tying of strands of suturematerial is required. The applicators of the present invention, all ofwhich can be configured as reusable, partially-reusable or entirelydisposable instruments, facilitate the use of the suture tie devices asdescribed above and depicted in the accompanying drawings and allow thesetting of multiple sutures at a surgical site without withdrawing theapplicator from the body.

Inasmuch as the present invention is subject to various modificationsand changes, the above description of preferred embodiments is intendedto be exemplary only and not limiting. Further variations and changeswhich may occur to persons of ordinary skill in the surgical suturingart are specifically intended to be encompassed by the accompanyingpatent claims.

What is claimed is:
 1. A suture tie device for suturing bodily tissue,comprisingat least one leg member having a proximal portion and a distalportion, at least one of said leg members comprising a tissue engagingportion, terminating at a distal end and having a configuration defininga tissue receiving space therein; and typing means selectivelydisplaceable along at least one of said leg members for engaging saiddistal end to form a suture loop.
 2. A suture tie device as recited inclaim 1, further comprising coupling means for inhibiting movement ofsaid tying means in at least a single predetermined direction along saidleg member.
 3. A suture tie device as recited in claim 2, wherein saidcoupling means is configured to permit distal movement of said tyingmeans and to inhibit proximal movement of said tying means.
 4. A suturetie device as recited in claim 2, wherein said tying means isselectively manipulable to release said coupling means to permitdisplacement of said tying means along said leg member.
 5. A suture tiedevice as recited in claim 2, wherein said tying means comprises alocking/tying member having an aperture formed therein for receivingsaid leg member and said coupling means comprises a plurality ofengaging members formed along at least one of said leg member and saidlocking/tying member.
 6. A suture tie device as recited in claim 2,wherein said coupling means comprises a plurality of engaging memberswhich are formed along a section of an exterior surface of said legmember and along an inner surface of said aperture of said locking/tyingmember.
 7. A suture tie device as recited in claim 6, wherein saidengaging members comprise a plurality of angularly extending teeth.
 8. Asuture tie device as recited in claim 6, wherein said engaging memberscomprise a plurality of filaments.
 9. A suture tie device as recited inclaim 6, wherein said engaging members comprise a plurality of outwardlyextending ridges.
 10. A suture tie device as recited in claim 6, whereinsaid engaging members comprise a plurality of micro-holes formed alongone of the leg member and the locking/tying member aperture, and atleast one filament formed on the other of the leg member andlocking/tying member aperture.
 11. A suture tie device as recited inclaim 6, wherein said engaging members comprise a plurality of ridgesand recesses arranged in an alternating configuration.
 12. A suture tiedevice as recited in claim 5, wherein said leg member is configured as agenerally tubular member having a wall which defines a tubular lumen anda generally longitudinally-extending slot extending between said tubularlumen and an exterior surface of said leg member, said locking/tyingmember comprising an arm that extends through said leg slot, saidlocking/tying member arm and said leg wall each being provided with aplurality of engaging members, said engaging members of said arm beingselectively displaceable into and out of engagement with said engagingmembers of said leg wall.
 13. A suture tie device as recited in claim 5,wherein the leg member defines a cavity at its proximal portion and thelocking/tying member further comprises a second aperture axially alignedwith a tip of the leg member distal end.
 14. A suture tie device asrecited in claim 13, further comprising a plug member comprising firstand second arms extending outwardly from a plate member and beinginsertable through corresponding ones of said locking/tying memberapertures, one of the plug arms being dimensioned so as to be receivedwithin the leg member cavity and the other of the plug arms defining anarm cavity that is dimensioned to be received within the distal end ofthe leg member.
 15. A suture tie device as recited in claim 5, whereinthe leg member defines a cavity at its proximal portion and an openingat its distal end, and the locking/tying member is provided with asecond aperture axially aligned with the distal end leg member opening.16. A suture tie device as recited in claim 15, further comprising aplug member comprising a pair of arms extending from a plate member,said plug arms being insertable through corresponding ones of saidlocking/tying member apertures, each of the arms being dimensioned so asto be insertable in a corresponding one of the leg member cavity anddistal end opening.
 17. A suture tie device as recited in claim 15,wherein the cavity extends from the proximal portion of the leg memberto the distal end opening.
 18. A suture tie device as recited in claim2, wherein the proximal portion of the leg member comprises a a collarmember defining a collar aperture having a plurality of engaging membersmounted along an interior surface of the collar aperture and the tyingmeans comprises a plug member insertable through said collar aperture,the plug member being provided with a plurality of engaging members forinteracting with the engaging members of said collar aperture.
 19. Asuture tie device as recited in claim 17, wherein the plug member isprovided with a distal end configuration complementary to theconfiguration of the tissue engaging portion of the leg member.
 20. Asuture tie device as recited in claim 15, wherein the plug member distalend configuration includes means for receiving the distal end of the legmember.
 21. A suture tie device as recited in claim 1, wherein the tyingmeans comprises means for receiving the distal end of the leg member.22. A suture tie device as recited in claim 1, wherein the proximalportion of the leg member is configured so as to be severable from thesuture tie device.
 23. A suture tie device as recited in claim 1,wherein at least a section of the leg member is formed from abioabsorbable material.
 24. A suture tie device as recited in claim 1,wherein both the leg member and the tying means are formed from abioabsorbable material.
 25. A suture tie device as recited in claim 1,wherein said tying means includes a recess formed therein foraccommodating tissue to be sutured.
 26. A suture tie device as recitedin claim 1, wherein the distal end of the leg member is configured witha sharp tip.
 27. A suture tie device as recited in claim 1, wherein thedistal end of the leg member is configured with a blunt tip.
 28. Asuture tie device as recited in claim 1, wherein the tissue receivingspace has a generally U-shaped configuration.
 29. A suture tie device asrecited in claim 1, wherein the distal end extends toward the proximalportion of the leg member.
 30. A method of suturing bodily tissue,comprising the steps of:engaging the bodily tissue with a suture tiedevice having a leg member comprised of a proximal portion and a distalportion that includes a tissue engaging portion terminating at a distalend and configured to define a tissue receiving space therein, and tyingmeans selectively displaceable along the leg member to engage the distalend thereof; approximating the bodily tissue within the tissue receivingspace of the suture tie device; advancing the tying means distally alongthe leg member toward the leg member distal end so as to form a sutureloop; and adjusting the position of the tying means along the leg memberto provide a desired level of tension in the suture loop.
 31. A methodaccording to claim 30, wherein the bodily tissue is engaged andpenetrated by a sharp distal edge provided along the distal end of thesuture tie device.
 32. A method according to claim 30, wherein thesuture tie device is applied to the bodily tissue by a suture tie deviceapplicator.
 33. A method according to claim 32, wherein bodily tissueengagement is accomplished by manipulating the applicator so as todirect the suture tie device along a curved path extending through thebodily tissue to be sutured.
 34. A method according to claim 32, whereinthe bodily tissue is engaged and penetrated by a distal end of theapplicator prior to tissue engagement by the suture tie device.
 35. Amethod according to claim 30, wherein the tying means and at least asection of the leg member are provided with coupling means comprising aplurality of mutually engageable engaging members, the method furthercomprising the step of selectively disengaging the plurality of mutuallyengageable engaging members to effect advancement of the tying meansalong the leg member of the suture tie device.
 36. A method according toclaim 35, further comprising the step of re-engaging the mutuallyengageable engaging members to inhibit movement of the tying means in atleast a single predetermined direction of movement.
 37. A methodaccording to claim 36, wherein re-engagement of the mutually engageableengaging members inhibits movement of the tying means along the legmember in a proximal direction.
 38. A method according to claim 36,wherein re-engagement of the mutually engageable engaging membersinhibits movement of the tying means along the leg member in both aproximal and a distal direction.
 39. A method according to claim 30,further comprising the step of severing a section of the proximalportion of the leg member following suture loop formation.
 40. A methodaccording to claim 30, wherein at least one part of the leg member andthe tying means of the suture tie device engaging the bodily tissue isformed from a bioabsorbable material.
 41. A method according to claim30, wherein the entire suture tie device engaging the bodily tissue isformed from a bioabsorbable material.
 42. A method according to claim30, further comprising the step of storing a plurality of suture tiedevices with the applicator and installing at least two of the pluralityof suture tie devices in the bodily tissue.
 43. A suture tie device forsuturing bodily tissue, comprisingat least two generally opposed legmembers, each of said leg members being provided with a proximal portionand a distal portion having a tissue engaging portion, said distaltissue engaging portion terminating at a distal end; and suture tyingmeans selectively displaceable a said generally opposed leg members forengaging said distal ends thereof to form a suture loop.
 44. A suturetie device as recited in claim 43, further comprising coupling means forinhibiting movement of said suture tying means in at least a singlepredetermined direction along said leg members.
 45. A suture tie deviceas recited in claim 44, wherein said coupling means is configured topermit distal movement of said suture tying means and to inhibitproximal movement of said suture tying means.
 46. A suture tie device asrecited in claim 44, wherein said suture tying means is selectivelymanipulable to release said coupling means to permit longitudinalmovement of said suture tying means along said leg members.
 47. A suturetie device as recited in claim 46, wherein said tying means comprises alocking/tying member having an aperture formed therein for receiving atleast one of said leg members, and said coupling means comprises aplurality of engaging members formed along a section of an exteriorsurface of said at least one leg member receivable within saidlocking/tying member aperture and along an inner surface of saidlocking/tying member aperture.
 48. A suture tie device as recited inclaim 47, wherein said engaging members comprise a plurality ofangularly extending teeth.
 49. A suture tie device as recited in claim47, wherein said engaging members comprise a plurality of filaments. 50.A suture tie device as recited in claim 47, wherein said engagingmembers comprise a plurality of outwardly extending ridges.
 51. A suturetie device as recited in claim 47, wherein said engaging memberscomprise a plurality of micro-holes formed along one of at least one ofthe two leg members and the locking/tying member aperture, and at leastone filament formed on another of the at least one of the two legmembers and locking/tying member aperture that is not provided with saidplurality of micro-holes.
 52. A suture tie device as recited in claim47, wherein said engaging members comprise a plurality of ridges andrecesses arranged in an alternating configuration.
 53. A suture tiedevice as recited in claim 43, wherein the generally opposed leg membersextend from a common base member.
 54. A suture tie device as recited inclaim 43, wherein the suture tie device is comprised of an even numberin excess of two leg members, the leg members being arranged ingenerally opposed pairs.
 55. A suture tie device as recited in claim 43,wherein an odd number of at least three leg members is provided.
 56. Asuture tie device as recited in claim 43, wherein the distal end portionof the leg members extend generally toward one another.
 57. A suture tiedevice as recited in claim 43, wherein one of the leg member distal endsis configured as a female member and another of the leg member distalends is configured as a male member, the female member having a lumenwhich is defined by an interior surface that is dimensioned to receivethe male member.
 58. A suture tie device as recited in claim 57, whereinthe male and female members are provided with means mutually engageablewith one another to effect interlocking engagement of the respective legmember distal ends.
 59. A suture tie device as recited in claim 58,wherein the distal end of the female member is provided with a pluralityof perforations that extend into the distal end lumen, and the malemember is provided with a plurality of locking protrusions that aredimensioned to be received within said perforations to effect saidinterlocking.
 60. A suture tie device as recited in claim 58, whereinthe interior surface of the female member is provided with at least onerib-like protrusion that extends into the distal end lumen, and the malemember is provided with a plurality of conical protrusions engageablewith said at least one rib-like protrusion to effect said interlocking.61. A suture tie device as recited in claim 58, wherein the interiorsurface of the female member is provided with at least one rib-likeprotrusion that extends into the distal end lumen, and the male memberis provided with a plurality of angled teeth engageable with said atleast one rib-like protrusion to effect said interlocking.
 62. A suturetie device as recited in claim 58, wherein the female member comprises aslot that divides the female member into at least two longitudinalsections, the lumen defined by the female member having a diameter thatis less than the diameter of the male member to be inserted therein. 63.A suture tie device as recited in claim 62, wherein the longitudinalsections are configured to resiliently engage the male member uponinsertion of the male member into the lumen of the female member.
 64. Asuture tie device as recited in claim 63, wherein the interior surfaceof the female member is provided with at least one rib-like protrusionthat extends into the distal end lumen, and the male member is providedwith a plurality of conical protrusions engageable with said at leastone rib-like protrusion to effect said interlocking.
 65. A suture tiedevice as recited in claim 58, wherein each of said distal ends includesa proximal surface and a distal surface, said interlocking means beingprovided along the distal surface of one of the distal ends and aproximal surface of another of the distal ends.
 66. A suture tie deviceas recited in claim 65, wherein the interlocking means comprises aprotruding member formed along one of said distal end surfaces and atleast one recess formed along the opposed surface of another of thedistal ends dimensioned to receive said protruding member.
 67. A suturetie device as recited in claim 43, wherein one of the distal ends isconfigured as a male member having a plurality of angled teeth extendingtherefrom and another of the distal ends comprises an aperturedimensioned to received said male member.
 68. A suture tie device asrecited in claim 67, wherein the distal end comprising the apertureterminates at a proximally-extending tip.
 69. A suture tie device asrecited in claim 43, wherein one of the distal ends is provided with aslot for receiving the distal end of another of the leg members.
 70. Asuture tie device as recited in claim 69, wherein the distal endreceived by said slot includes a recess engageable with a portion of thedistal end defining said slot.
 71. A suture tie device as recited inclaim 43, wherein said at least two leg members are displaceable towardone another.
 72. A suture tie device as recited in claim 43 wherein oneof said leg members is displaceably fixed in position relative to theother of said leg members.
 73. A suture tie device as recited in claim43, wherein at least one of said leg members is provided with a recessadjacent the distal end of the leg member for receiving bodily tissuetherein.
 74. A suture tie device as recited in claim 43, wherein thetying means comprises means for receiving the distal end of at least oneof the leg members.
 75. A suture tie device as recited in claim 43,wherein each of the distal ends of the opposed leg members terminates ata distal tip, the distal tips being configured so as to be positionablein a generally parallel relation relative to one another.
 76. A suturetie device as recited in claim 75, wherein at least one of the distaltips is provided with a sharp edge.
 77. A suture tie device as recitedin claim 76, wherein said sharp edge has a jagged configuration.
 78. Asuture tie device as recited in claim 75, wherein at least one of thedistal tips is provided with a blunt edge.
 79. A suture tie device asrecited in claim 75, wherein the distal tips are configured to bepositionable in a parallel, angularly inclined orientation relative to alongitudinal axis of the suture tie device.
 80. A suture tie device asrecited in claim 43, wherein the proximal portion of at least one of theleg members is configured to be severable from the suture tie device.81. A suture tie device as recited in claim 43, wherein at least asection of at least one of the leg members is formed from abioabsorbable material.
 82. A suture tie device as recited in claim 43,wherein all of the leg members and the tying means are formed from abioabsorbable material.
 83. A suture tie device as recited in claim 43.wherein the tying means includes a recess formed therein foraccommodating tissue to be sutured.
 84. An applicator in combinationwith a suture tie device for suturing tissue, the applicator beingapplicable for use in applying the suture tie device to anatomicaltissue, the suture tie device having at least one tissue engaging legmember and a locking/tying member movable along the leg member, theapplicator comprising:an elongate outer member having a proximal portionand a distal portion for holding a suture tie device in a tissuesuturing position; means for storing a plurality of suture tie devices;means for engaging the locking/tying member of the suture tie device;handle means connected with the proximal portion of said outer elongatemember and said engaging means for selectively advancing said engagingmeans distally relative to said outer elongate member to advance thelocking/tying member along the tissue engaging leg member to effectsuturing of anatomical tissue positioned between said leg member andsaid locking/tying member at said outer member distal portion; andactuator means for delivering a suture tie device from said storingmeans to said distal portion of said outer elongate member; and meansfor effecting release of at least one suture tie device into theanatomical tissue following distal advancement of said locking/tyingmember thereof.
 85. 1. An applicator as recited in claim 84, whereinsaid storing means comprises a housing for storing a plurality of suturetie devices in an end-to-end serial arrangement and means for retainingthe suture tie devices in said housing, said retaining means beingselectively displaceable relative to a distal end of said storing meansto permit release of a suture tie device toward said distal portion ofsaid outer elongate member.
 86. An applicator as recited in claim 85,wherein said housing is provided with a generally tubular configurationhaving a proximal end and a distal end, said actuator means beingdisposed adjacent said housing proximal end and said retaining meansbeing disposed adjacent said housing distal end.
 87. An applicator asrecited in claim 86, wherein said retaining means includes at least tworadially displaceable arms which extend from said housing distal end.88. An applicator as recited in claim 86, wherein said retaining meansincludes at least two radially displaceable arms which extend from saidouter elongate member adjacent said distal portion thereof.
 89. Anapplicator as recited in claim 88, wherein said retaining meanscomprises at least one resilient guide member disposed in said housing.90. An applicator as recited in claim 86, wherein said housing comprisestwo coaxially arranged generally elongate members, one of the generallyelongate members being provided with at least two radially expandablearms extending from a distal end of the elongate member, the othergenerally elongate member including means for manipulating said radiallyexpandable arms, said actuator means being operable to effect distal andproximal movement of said elongate members relative to one another. 91.An applicator as recited in claim 90, wherein the outermost of the twoelongate members is provided with said radially expandable arms and theinner elongate member is configured such that distal movement thereofrelative to said outer elongate member effects radial expansion of saidradially expandable arms.
 92. An applicator as recited in claim 90,wherein said inner elongate member further comprises means to connectthe distal end of said inner elongate member with said radiallyexpandable arms such that proximal movement of said inner elongatemember relative to said outer elongate member effects said radiallyexpandable arms to move toward one another.
 93. An applicator as recitedin claim 90, wherein said inner elongate member is provided with saidradially expandable arms, said outer and inner elongate members beingarranged relative to one another such that proximal movement of saidouter elongate member relative to said inner elongate member effectsradial expansion of said expandable arms.
 94. An applicator as recitedin claim 90, wherein said inner elongate member is provided with saidradially expandable arms, said outer and inner elongate members beingarranged relative to one another such that distal movement of said outerelongate member relative to said inner elongate member effects saidradially expandable arms to move toward one another.
 95. An applicatoras recited in claim 90, further comprising means for selectivelyadjusting the relative spacing between ends of the radially expandablearms.
 96. An applicator as recited in claim 90, wherein ends of saidradially expandable arms are provided with sharp edges for severing aportion of the tissue engaging leg.
 97. An applicator as recited inclaim 90, further comprising means for locking the handle in auser-selected position.
 98. An applicator as recited in claim 84,wherein said distal portion of said outer elongate member comprises acradle for receiving a suture tie device to be applied to the tissue tobe sutured.
 99. An applicator as recited in claim 98, wherein the cradleterminates at a sharp distal end.
 100. An applicator as recited in claim84, wherein the storing means comprises a replaceable housing having aplurality of suture tie devices serially arranged therein.
 101. Anapplicator as recited in claim 84, wherein the applicator is configuredas a disposable instrument for use with a single patient.
 102. Anapplicator as recited in claim 84, wherein said distal portion of saidouter elongate member comprises at least two forcep arms, each of saidforcep arms being configured to receive a leg member of the suture tiedevice.
 103. An applicator as recited in claim 102, further comprisingmeans for displacing one forcep arm relative to the other of the atleast two forcep arms.
 104. An applicator as recited in claim 102,wherein one of said forcep arms comprises means for receiving another ofthe forcep arms.
 105. An applicator as recited in claim 104, whereinsaid forcep arm receiving means comprises a lumen formed in said forceparm.
 106. An applicator as recited in claim 102, wherein at least one ofsaid forcep arms terminates at a sharp distal tip.
 107. An applicator asrecited in claim 102, further comprising means for inhibiting distalmovement of the suture tie device locking/tying member beyond apredetermined position of the applicator.
 108. An applicator device incombination with a suture tie device, the applicator being applicablefor use in applying the suture tie device to anatomical tissue, the tiedevice including at least one elongate, tissue-engaging member having adistal end configured to engage tissue and a proximal end, andtying/locking means received on the tissue engaging member proximal endand movable toward the tissue engaging member distal end to lock tissuetherewithin, the applicator device including an inner, elongate memberreceived telescopically within a middle tubular member which, in turn,is telescopically received within an outer, elongate tubular member,said inner, middle and outer tubular members each having a distal endand a proximal end, said outer tubular member distal end having meansfor temporarily receiving a suture tie device therewithin, said innermember distal end abutting the tissue engaging member proximal end toretain the suture tie device within the tie device receiving means, saidmiddle tubular member distal end being configured and dimensioned toengage the tying/locking means, whereby upon sliding movement of saidmiddle tubular member with respect to said inner member and towards thedistal end thereof, the tying/locking means is caused to slide along thetissue engaging member towards the distal end thereof, said tissueengaging member proximal end being configured to initially receive saidtying/locking means, said tissue engaging member being configured sothat said tying/locking means is displaceable along said tissue engagingmember from said proximal end toward said distal end to lock tissuetherewithin, means being provided on said tissue engaging member andsaid tying/locking means for permitting movement of said locking meanstowards said tissue engaging member distal end and for preventingmovement of said tying/locking means toward said tissue engaging memberproximal end, said tissue engaging member comprising a base memberpositioned adjacent said tissue engaging member proximal end and a pairof jaws extending from said base member in the distal direction, saidjaws being displaceable between an open position and a generally closedposition, said locking means comprising a ring-like locking memberhaving a configuration and internal dimensions generally mating theexternal dimensions and configuration of said base member, said jawsbeing configured to receive tissue when open and to lock tissuetherewithin when in the generally closed position upon sliding of saidlocking member over said base member and said jaws towards said tissueengaging member distal end, thereby closing said jaws a desired distancein accordance with the amount of sliding movement of said lockingmember.
 109. The applicator device as claimed in claim 108, furthercomprising generally U-shaped handle means having first and secondhandle members, said first handle member being fixed to said outertubular member proximal end and said second handle member being fixed tosaid middle tubular member proximal end, whereupon a grasping, squeezingaction of said generally U-shaped handle means effects displacement ofthe middle tubular member toward and beyond the distal end of the innermember.
 110. The applicator device as claimed in claim 108, wherein saidouter tubular member distal end means for temporarily receiving a suturetie device therewithin comprise forceps means, constructed so as to bein a normally open configuration, said applicator further comprising asupplemental outer tubular member telescopically mounted over said outertubular member and having a distal end and a proximal end, saidsupplemental outer tubular member being displaceable relative to saidouter tubular member to effect displacement of said forcep means betweenan open and a closed position.
 111. The applicator device as claimed inclaim 108, wherein said outer tubular member distal end means fortemporarily receiving a suture tie device therewithin comprise an opencradle with a closed distal end.
 112. The applicator device as claimedin claim 108, wherein said middle tubular member is internallydimensioned and configured to receive a plurality of suture tie devicestherewithin, in end-to-end series fashion.
 113. An applicator device foruse in applying a suture tie device to anatomical tissue, the tie deviceincluding at least one elongate, tissue engaging member having a distalend and a proximal end and a locking member received on the tissueengaging member proximal end and movable toward the tissue engagingmember distal end to lock tissue therewithin, the applicator devicecomprising: an inner, elongate member received telescopically within amiddle tubular member which, in turn, is telescopically received withinan outer, elongate tubular member, said inner, middle and outer tubularmembers each having a distal end and a proximal end, said outer tubularmember distal end having means for temporarily receiving a suture tiedevice therewithin, said inner member distal end abutting the tissueengaging member proximal end to retain the tie device within the tiedevice receiving means, said middle tubular member distal end beingconfigured and dimensioned to engage the device locking member, wherebyupon sliding movement of said middle tubular member with respect to saidinner member and towards the distal end thereof, the locking member iscaused to slide along the tissue engaging member towards the distal endthereof, wherein said outer tubular member distal end means fortemporarily receiving a tie device therewithin comprise forceps means,constructed so as to be in a normally open configuration, saidapplicator further comprising an additional outer tubular membertelescopically mounted over said outer tubular member and having adistal end and a proximal end, said additional tubular member beingmovable along said outer tubular member, over and beyond the distal endthereof thus to close said forceps means, wherein said forceps meansinclude distal end cooperating cutting means for severing a proximalportion of a tissue engaging member of the tie device after the engagingmember is locked by the locking member thereof.
 114. An applicatordevice in combination with a suture tie device, the applicator beingapplicable for use in applying a suture tie device to anatomical tissue,the tie device including at least one elongate, tissue-engaging memberhaving a distal end provided with open hook means for securing tissue, aproximal end, and a ring-like locking member received on the tissueengaging member proximal end and movable toward the tissue engagingmember distal end to substantially close said open hook means to locktissue therewithin, means being provided along said tissue engagingmember and said locking member for permitting movement of said lockingmember toward said tissue engaging member distal end and for inhibitingmovement of said locking member toward said tissue member proximal end,the applicator device including an inner, elongate member receivedtelescopically within a middle tubular member which, in turn, istelescopically received within an outer, elongate tubular member, saidinner, middle and outer tubular members each having a distal end and aproximal end, said outer tubular member distal end having means fortemporarily receiving a suture tie device therewithin, said inner memberdistal end abutting the tissue engaging member proximal end to retainthe suture tie device within the tie device receiving means, said middletubular member distal end being configured and dimensioned to engage atie device locking member, whereby upon distal sliding movement of saidmiddle tubular member with respect to said inner member, the lockingmember is directed to slide along the tissue engaging member towards thedistal end thereof.